The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for delivering high frequency electrotherapy to tissue.

Device Description

The Sectum control unit is a radiofrequency energy generator employed for a variety of aesthetic applications. The control unit output is set and monitored via touchscreen and controlled by foot switch. The control unit can be used with corded bipolar Precision and Body applicators.

AI/ML Overview

The Neauvia Sectum System's acceptance criteria and the study proving it meets these criteria are described below. The device in question is a high-frequency electrosurgical generator intended for topical heating to elevate tissue temperature for conditions such as pain and muscle spasms, increased local circulation, and temporary reduction of cellulite.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided document focuses on substantial equivalence to a predicate device (Venus Legacy CX) through non-clinical evidence and compliance with electrical safety and EMC standards. Therefore, the "acceptance criteria" can be inferred from these compliance requirements and the performance aspects compared to the predicate.

Acceptance Criteria (Inferred from Non-Clinical Evidence)	Reported Device Performance
Compliance with Electrical Safety Standards (IEC 60601-1, IEC 60601-2-2)	Passed: Verified and validated through testing.
Compliance with Electromagnetic Compatibility (EMC) Standards (IEC 60601-1-2)	Passed: Verified and validated through testing.
Compliance with Usability Standards (IEC 60601-1-6)	Passed: Verified and validated through testing.
Compliance with Alarm Systems Standards (IEC 60601-1-8)	Passed: Verified and validated through testing.
Software Verification and Validation	Completed: Conducted and documented in accordance with FDA guidance for software in medical devices.
Ability to maintain tissue temperatures within therapy-specific limits (Skin surface temperature)	Proven: Skin surface temperature testing completed successfully, demonstrating the device's ability to maintain tissue temperatures within specified therapeutic ranges.
Biocompatibility of Patient-Contacting Materials (ISO 10993-1, ISO 10993-5, ISO 10993-10)	Compliant: Cytotoxicity and irritation testing showed components in patient contact are not cytotoxic (per ISO 10993-5) or irritating (per ISO 10993-10).
Substantial Equivalence to Predicate Device (Venus Legacy CX) in Performance, Options, and Size	Confirmed: The document states, "The subject devices included in The Neauvia Sectum System are substantially equivalent to predicate device in performance, options, and size. The system emits RF current to heat body and face tissues." The comparison table on page 4 details similar intended use, technological characteristics (e.g., RF energy, footswitch activation, touchscreen interface, bipolar mode, temperature sensors) despite some differences in specific parameters (e.g., Max Power Output, additional energy delivered features in predicate like PMF, Vacuum). The conclusion explicitly states, "The similar technological characteristics, indications for use and results of performance testing support the substantial equivalence of the Neauvia Sectum to the predicate device."

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in the context of human subjects or patient data. The provided evidence is based on non-clinical testing (e.g., electrical safety, EMC, software validation, skin surface temperature testing, and biocompatibility). Therefore, sample size and data provenance in terms of country of origin or retrospective/prospective nature are not applicable for these types of engineering and laboratory tests.

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

Since the evidence is non-clinical testing and not based on human-read interpretations of medical images or diagnoses, the concept of "experts establishing ground truth for a test set" is not applicable in the traditional sense for this submission. The "ground truth" for these tests refers to the established standards and accepted scientific methodologies for proving compliance (e.g., passing electrical safety tests according to IEC standards). These tests would be conducted by qualified engineers and technicians in certified testing laboratories.

4. Adjudication method for the test set:

Not applicable, as there is no test set involving human interpretation requiring an adjudication method.

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. The device is a high-frequency electrosurgical generator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a medical instrument and not an algorithm. Its performance is demonstrated through its functional capabilities, safety, and biocompatibility, as evaluated through non-clinical tests.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests were established technical standards and validated testing protocols. For example:

Electrical Safety, EMC, Usability, Alarm Systems: Compliance with specific IEC 60601 series standards.
Software Validation: Adherence to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Skin Surface Temperature Testing: Defined therapeutic temperature limits.
Biocompatibility: Adherence to ISO 10993 series standards (ISO 10993-1, -5, -10).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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July 30, 2021

Neauvia North America Jov Willard Director of Quality, Regulatory and Clinical Affairs 8480 Honeycutt Road Raleigh, North Carolina 27615

Re: K202780

Trade/Device Name: Sectum System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: June 30, 2021 Received: July 1, 2021

Dear Joy Willard:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4 , Subpart A ) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation -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).

Sincerely.

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) K202780

Device Name Sectum

Indications for Use (Describe)

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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510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Neauvia Sectum System

(a)(1). Submitted By:	Neauvia North America. 8480 Honeycutt Rd. Raleigh, NC 27615 United States of America
Contact Person:	Joy Willard Director of Quality, Regulatory and Clinical Affairs Telephone - (984) 777-5296 Email - joy@neauvia-us.com
Date:	June 29, 2021
(a)(2). Proprietary Name:	Sectum System
Common Name(s):	Electrosurgical generator, Radio Frequency Induced Heat
Classification Name:	21 CFR 878.4400 Electrosurgical Cutting and Coagulation and Accessories
Regulatory Class:	II
Product Codes:	PBX, GEI
Classification Panel:	General & Plastic Surgery
(a)(3). Predicate Devices:	K143554 - Venus Legacy CX Venus Concept Ltd., Weston FL, USA
Reference Devices:	K203144 - MicroPen Evo K210129 - RF Thermal System

(a)(4). Device Description

(a)(5). Indications for Use

The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as reliefof pain and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for deliveringhigh frequency electrotherapy to tissue.

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(a)(6). Substantial Equivalence: - Technological Characteristics

The subject devices included in The Neauvia Sectum System are substantially equivalent to predicate device in performance, options, and size. The system emits RF current to heat body and face tissues.

The following table compares the Sectum device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

Description	Subject Device	Venus Legacy CX
	Neauvia Sectum Electrosurgical Generator	Venus Concept Ltd.
	with 2 applicators: BODY and PRECISION	(K143554)
Class,ProductCode,Regulation	Class II, PBX & GEI, 21 CFR 878.4400	Class II, GEI & PBX, 21 CFR 878.4400
Indicationsfor Use	The Sectum control unit is a high frequencygenerator intended to provide topical heatingfor the purpose of elevating tissue temperaturefor the treatment of selected medicalconditions, such as relief of pain and musclespasms and increase in local circulation andprovide a temporary reduction in theappearance of cellulite. The Sectum controlunit utilizes a BODY and PRECISIONapplicator for delivering high frequencyelectrotherapy to tissue.	The Venus Legacy CX device is intendedfor the treatment of the following medicalconditions; using the LB2 and LF2applicators for delivery of non-thermal RFcombined with massage and magnetic fieldpulses:• Relief of minor muscles aches andpain, relief of muscle spasm• Temporary improvement of local bloodcirculation• Temporary reduction in the appearancecellulite
Method ofActivation	Footswitch	Footswitch or finger switch
UserInterface	Touchscreen on front of generator allows userto select mode and output	Touchscreen on front of generator allowsuser to select mode and output
EnergyDelivered	RF EnergyMassage	RF EnergyPulsed Magnetic Field (PMF)Vacuum
ModesAvailable	BIPOLAR	BIPOLAR
Max PowerOutput	BODY: 100WPRECISION: 100W	Up to 150W
TemperatureSensors	Applicators are equipped with treatment areatemperature monitoring system	Applicators are equipped with treatmentarea temperature monitoring system
Outputfrequency	480 kHz for Bipolar Precision and Bodyapplicators	Not Listed
MaxVoltageOutput	1 kV	Not Listed
LineFrequency	50/60 Hz	Not Listed
Control UnitWeight	5 kg	Not Listed
Control UnitDimensions	410 x 325 x 155 mm	Not Listed
ApplicatorDimensions, weight	Body: 145 x 140 x 100 mm, 345gPrecision: 180 x 75 x 50 mm, 150g	Not Listed
Applicator:number ofelectrodes	Body: 6Precision: 2	4D Body: 8
StandardsCompliance	IEC60601-1IEC60601-1-2IEC60601-2-2IEC60601-1-6IEC60601-1-8	IEC60601-1IEC60601-1-2IEC60601-2-2

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(b)(1). Substantial Equivalence: - Non-Clinical Evidence

Verification and validation activities were successfully completed and establish that the Sectum control unit performs as intended. Testing included the following:

Compliance with Electrical Safety and EMC standards:

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
IEC 60601-2-2:2009 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

IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8:2006 + A1:2012 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices. This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Skin surface temperature testing was completed proving the device is able to maintain tissue temperatures within the therapy specific limits.

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Biocompatibility testing was evaluated on patient contacting materials per ISO 10993-1. Cytotoxicity and irritation testing show the components with patient contact are not cytotoxic per ISO 10993-5 or irritating per ISO 10993-10.

(b)(3). Substantial Equivalence - Conclusions

Neauvia Sectum device does not raise any new concerns of safety and efficacy compared to the predicate devices. The similar technological characteristics, indications for use and results of performance testing support the substantial equivalence of the Neauvia Sectum to the predicate device.

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.