(311 days)
No
The summary describes a radiofrequency energy generator with touchscreen control and foot switch operation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on electrical safety, software verification, temperature testing, and biocompatibility, not AI/ML performance metrics.
Yes
The device is described as a high-frequency generator intended to provide topical heating for the treatment of selected medical conditions such as muscle spasms, increase in local circulation, and temporary reduction in the appearance of cellulite. These are therapeutic applications.
No
The device is described as a high-frequency generator for therapeutic purposes (topical heating, reducing muscle spasms, increasing local circulation, temporary reduction in cellulite appearance), not for diagnosing medical conditions.
No
The device description explicitly states it is a "radiofrequency energy generator" and a "control unit" that utilizes "applicators" and is controlled by a "foot switch," all of which are hardware components. The summary also mentions "Electrical Safety and EMC standards" and "Biocompatibility testing," which are typically associated with hardware devices.
Based on the provided information, the Sectum control unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions." This involves applying energy directly to the patient's body.
- Device Description: The description confirms it's a "radiofrequency energy generator employed for a variety of aesthetic applications." This is an energy-based therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose or monitor a condition.
IVD devices are designed to perform tests on biological samples to provide information about a person's health status. The Sectum control unit is a therapeutic device that applies energy to the body.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
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.
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
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)
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.
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.
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.
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
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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.
1
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)
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)
| 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
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, | ||
| Product | ||
| Code, | ||
| Regulation | Class II, PBX & GEI, 21 CFR 878.4400 | Class II, GEI & PBX, 21 CFR 878.4400 |
| 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 relief of pain and muscle | ||
| spasms and 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. | The Venus Legacy CX device is intended | |
| for the treatment of the following medical | ||
| conditions; using the LB2 and LF2 | ||
| applicators for delivery of non-thermal RF | ||
| combined with massage and magnetic field | ||
| pulses: | ||
| • Relief of minor muscles aches and | ||
| pain, relief of muscle spasm | ||
| • Temporary improvement of local blood | ||
| circulation | ||
| • Temporary reduction in the appearance | ||
| cellulite | ||
| Method of | ||
| Activation | Footswitch | Footswitch or finger switch |
| User | ||
| Interface | Touchscreen on front of generator allows user | |
| to select mode and output | Touchscreen on front of generator allows | |
| user to select mode and output | ||
| Energy | ||
| Delivered | RF Energy | |
| Massage | RF Energy | |
| Pulsed Magnetic Field (PMF) | ||
| Vacuum | ||
| Modes | ||
| Available | BIPOLAR | BIPOLAR |
| Max Power | ||
| Output | BODY: 100W | |
| PRECISION: 100W | Up to 150W | |
| Temperature | ||
| Sensors | Applicators are equipped with treatment area | |
| temperature monitoring system | Applicators are equipped with treatment | |
| area temperature monitoring system | ||
| Output | ||
| frequency | 480 kHz for Bipolar Precision and Body | |
| applicators | Not Listed | |
| Max | ||
| Voltage | ||
| Output | 1 kV | Not Listed |
| Line | ||
| Frequency | 50/60 Hz | Not Listed |
| Control Unit | ||
| Weight | 5 kg | Not Listed |
| Control Unit | ||
| Dimensions | 410 x 325 x 155 mm | Not Listed |
| Applicator | ||
| Dimensions, weight | Body: 145 x 140 x 100 mm, 345g | |
| Precision: 180 x 75 x 50 mm, 150g | Not Listed | |
| Applicator: | ||
| number of | ||
| electrodes | Body: 6 | |
| Precision: 2 | 4D Body: 8 | |
| Standards | ||
| Compliance | IEC60601-1 | |
| IEC60601-1-2 | ||
| IEC60601-2-2 | ||
| IEC60601-1-6 | ||
| IEC60601-1-8 | IEC60601-1 | |
| IEC60601-1-2 | ||
| 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.
6
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.