Sectum

K202780 · Neauvia North America · PBX · Jul 30, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202780
• Device Name: Sectum
• Applicant: Neauvia North America
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Jul 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 relief of 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 delivering high frequency electrotherapy to tissue.

Device Story

Sectum System is a radiofrequency (RF) energy generator for aesthetic applications; utilizes corded bipolar 'BODY' and 'PRECISION' applicators to deliver high-frequency electrotherapy to tissue. Device operates via touchscreen interface and footswitch activation; includes integrated temperature monitoring system for treatment areas. Used in clinical settings by healthcare professionals to elevate tissue temperature. Output is 480 kHz RF current; max power 100W. Benefits include pain relief, muscle spasm reduction, improved local circulation, and temporary cellulite reduction. Device does not use vacuum or magnetic fields, distinguishing it from some multi-modal predicates.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only. Verification activities included electrical safety (IEC 60601-1, 60601-1-2, 60601-2-2, 60601-1-6, 60601-1-8), biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation), and skin surface temperature testing to confirm therapy limits.

Technological Characteristics

RF generator; 480 kHz output frequency; 100W max power. Bipolar mode. Applicators: BODY (6 electrodes) and PRECISION (2 electrodes). Integrated temperature monitoring. Standards: IEC 60601-1, 60601-1-2, 60601-2-2, 60601-1-6, 60601-1-8. Biocompatible materials per ISO 10993. Dimensions: 410 x 325 x 155 mm (control unit). Weight: 5 kg.

Indications for Use

Indicated for patients requiring topical heating for relief of pain, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite.

Regulatory Classification

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.

Predicate Devices

• Venus Legacy CX (K143554)

Reference Devices

• MicroPen Evo (K203144)
• RF Thermal System (K210129)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span style="font-size:10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:none;stroke:#000000;stroke-width:1" width="10"></rect> <path d="M1 1 L9 9 M9 1 L1 9" style="stroke:#000000;stroke-width:1"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-size:10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:none;stroke:#000000;stroke-width:1" width="10"></rect> </svg> </span> 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 - [phone] Email - [e-mail] |
| 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

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.

## (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,<br>Product<br>Code,<br>Regulation | Class II, PBX & GEI, 21 CFR 878.4400 | Class II, GEI & PBX, 21 CFR 878.4400 |
| Indications<br>for Use | The Sectum control unit is a high frequency<br>generator intended to provide topical heating<br>for the purpose of elevating tissue temperature<br>for the treatment of selected medical<br>conditions, such as relief of pain and muscle<br>spasms and increase in local circulation and<br>provide a temporary reduction in the<br>appearance of cellulite. The Sectum control<br>unit utilizes a BODY and PRECISION<br>applicator for delivering high frequency<br>electrotherapy to tissue. | The Venus Legacy CX device is intended<br>for the treatment of the following medical<br>conditions; using the LB2 and LF2<br>applicators for delivery of non-thermal RF<br>combined with massage and magnetic field<br>pulses:<br>• Relief of minor muscles aches and<br>pain, relief of muscle spasm<br>• Temporary improvement of local blood<br>circulation<br>• Temporary reduction in the appearance<br>cellulite |
| Method of<br>Activation | Footswitch | Footswitch or finger switch |
| User<br>Interface | Touchscreen on front of generator allows user<br>to select mode and output | Touchscreen on front of generator allows<br>user to select mode and output |
| Energy<br>Delivered | RF Energy<br>Massage | RF Energy<br>Pulsed Magnetic Field (PMF)<br>Vacuum |
| Modes<br>Available | BIPOLAR | BIPOLAR |
| Max Power<br>Output | BODY: 100W<br>PRECISION: 100W | Up to 150W |
| Temperature<br>Sensors | Applicators are equipped with treatment area<br>temperature monitoring system | Applicators are equipped with treatment<br>area temperature monitoring system |
| Output<br>frequency | 480 kHz for Bipolar Precision and Body<br>applicators | Not Listed |
| Max<br>Voltage<br>Output | 1 kV | Not Listed |
| Line<br>Frequency | 50/60 Hz | Not Listed |
| Control Unit<br>Weight | 5 kg | Not Listed |
| Control Unit<br>Dimensions | 410 x 325 x 155 mm | Not Listed |
| Applicator<br>Dimensions, weight | Body: 145 x 140 x 100 mm, 345g<br>Precision: 180 x 75 x 50 mm, 150g | Not Listed |
| Applicator:<br>number of<br>electrodes | Body: 6<br>Precision: 2 | 4D Body: 8 |
| Standards<br>Compliance | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-2<br>IEC60601-1-6<br>IEC60601-1-8 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-2 |

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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.