(231 days)
No
The device description and performance studies focus on radiofrequency energy delivery and its effects, with no mention of AI or ML technologies.
Yes.
The device is intended to treat conditions such as temporary relief of pain, muscle spasms, and increase in local circulation, temporary reduction in the appearance of cellulite, and abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity, all of which fall under therapeutic uses.
No
Explanation: The device is intended for therapeutic purposes such as temporary pain relief, muscle spasm treatment, increased circulation, temporary reduction of cellulite appearance, and abdominal circumference reduction through heat-induced lipolysis. It does not diagnose conditions.
No
The device description clearly outlines hardware components such as radiofrequency generators, electrodes, handpieces, and a footswitch, indicating it is a physical medical device that utilizes software for control and operation, but is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (topical heating for pain/spasms/circulation, cellulite reduction, abdominal circumference reduction, skin laxity improvement) are all related to treating conditions or altering the physical appearance of the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) from the body to diagnose diseases or conditions.
- Device Description: The device description details how the device applies radio frequency energy to the patient's tissue through electrodes in contact with the skin. This is a direct treatment method, not a method for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.
The device is clearly intended for therapeutic and aesthetic applications directly on the patient's body, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The NuEra Tight RF and NuEra Tight RF Plus are intended:
-
to provide topical heating for the purpose of elevating tissue temperature for the treatment of conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
-
to provide, with a massage device, a temporary reduction in the appearance of cellulite.
-
to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
NuEra Tight RF and NuEra Tight RF Plus are designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically,
-
NuEra Tight RF radiofrequency generator with single RF electrode connector. -
-
NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.
The treatment performed by the NuEra Tight RF models consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.
One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.
One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.
All the handpieces are intended to be used with a small amount (approximately 1 mm layer) of an RF conductive cream (Parker Redux cream, cleared under K782055, or similar cream available in the US). The purpose of the cream is to provide aid to transfer the heat.
A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.
The pause handpiece is an optional accessory can be used to pause the treatment without using the GUI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
Indicated Patient Age Range
21.7-65.4 years
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)
Clinical study, multi-arm, prospective, randomized, multi-center.
Sample Size: 82 enrolled and randomized subjects.
- For the 82 enrolled and randomized subjects:
- mean age of 46.8±11.3 years, with a range of 21.7-65.4 years; ●
- seventy-two (72) females and 10 males;
- self-identified to be: White (79%); Other (10%); Black or African American (6%); or ● Asian (5%), and to be of Hispanic or Latino ethnicity (13%); and,
- mean circumference of 85.93±8.51 cm, with a range of 67.93-104.6 cm.
Key Results:
Primary Effectiveness Endpoint: The mean change (reduction) from baseline in waist circumference at 12 weeks follow up was found to be statistically significant in the 1 MHz (n=23) and 2 MHz (n=18) groups.
Secondary Effectiveness Endpoints:
- Skin laxity: Blinded assessors evaluated before/after pictures and identified improvement in skin laxity in a majority of subjects at the 4 and 12 week follow up visits.
- Aesthetic appearance: Investigators and subjects were asked to assess aesthetic appearance after each visit (GAIS score). The majority in each group reported improvement in appearance.
- In addition, blinded reviewers were asked to identify which photos of subjects (per visit and treatment arm in subjects who completed the study course and appeared for all followup visits) were 'before treatment' and 'after treatment' pictures. The results were that most pictures were correctly identified by the blinded reviewers.
Safety: - The median VAS Score was 0, with 50% of the subjects reported no pain or discomfort ● during any of the treatments and the average pain for all treatment arms was 1.6 (lowlevel of pain).
- One subject from the 2 MHz arm had a mild burn that was deemed related to the procedure, the adverse event (AE) resolved with no action taken (1/276 treatments, 0.3%).
- There were 2 AEs considered by the investigators as possibly related to the device or the procedure (diarrhea and back pain). The events were mild and resolved with no action.
- None of the AEs was considered serious. ●
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2023
BIOS s.r.l. Manuela Brambilla Regional Regulatory Affairs Leader Via Guido Rossa 10/12 Vimodrone, MI 20055 Italy
Re: K223856
Trade/Device Name: NuEra Tight RF Family Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: July 14, 2023 Received: July 14, 2023
Dear Manuela Brambilla:
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/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.
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
1
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 (OS) 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 mediation-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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Mark Trumbore and was signed on August 11, 2023 at 11:59:57 -04'00'. The signature appears to be an official digital signature.
Mark Trumbore, 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
2
Indications for Use
510(k) Number (if known)
K223856
Device Name NuEra Tight RF and NuEra Tight RF Plus
Indications for Use (Describe) The NuEra Tight RF and NuEra Tight RF Plus are intended:
-
to provide topical heating for the purpose of elevating tissue temperature for the treatment of conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
-
to provide, with a massage device, a temporary reduction in the appearance of cellulite.
-
to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "bios" in a stylized font, with the "i" dotted with a small circle. Below the word "bios" is the phrase "by Lumenis", where the "L" in Lumenis is stylized with a blue circle around it. The text is in a sans-serif font and appears to be part of a logo or branding material.
510(k) Summary
| 510(k) Number | K223856 |
|---|---|
| 510(k) Type | Traditional |
| Applicant Information | Bios s.r.l. |
| Via Guido Rossa, 10/12 | |
| 20055 Vimodrone (MI) – Italy | |
| Contact | Eng. Manuela Brambilla |
| Phone: 0039-02-27304275 | |
| Email: regulatory@biosgroup.eu | |
| Date Prepared | August 10, 2023 |
| Device Name | NuEra Tight RF and NuEra Tight RF Plus |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Regulatory Class | Class II (21CFR§878.4400) |
| Product Codes | GEI, PBX |
| Regulation Name | Electrosurgical cutting and coagulation device and accessories |
Predicate and Reference Devices
| 510(k) Ref | Pro Code/Reg No | Trade Name | Applicant |
|---|---|---|---|
| Predicate Device | |||
| K210867 | PBX, 878.4400 | NuEra Tight RF and NuEra Tight RF Plus | Bios s.r.l. |
| Reference Device | |||
| K162512 | GEI, PBX, 878.4400 | truSculpt | Cutera, Inc. |
| K163415 | GEI, 878.4400 | SlimShape | Syneron Medical Ltd. |
Device Description
NuEra Tight RF and NuEra Tight RF Plus are designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically,
- NuEra Tight RF radiofrequency generator with single RF electrode connector. -
4
Image /page/4/Picture/0 description: The image shows the logo for "bios by Lumenis". The word "bios" is written in a sans-serif font, with the "i" having a curved top. Below "bios" is the text "by Lumenis", with the "L" in "Lumenis" being a stylized blue "U" shape.
- NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.
The treatment performed by the NuEra Tight RF models consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.
One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.
One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.
All the handpieces are intended to be used with a small amount (approximately 1 mm layer) of an RF conductive cream (Parker Redux cream, cleared under K782055, or similar cream available in the US). The purpose of the cream is to provide aid to transfer the heat.
A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.
The pause handpiece is an optional accessory can be used to pause the treatment without using the GUI.
Indications for Use
The NuEra Tight RF and NuEra Tight RF Plus are intended:
- . to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
- to provide, with a massage device, a temporary reduction in the appearance of cellulite.
- to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference 트 reduction with adjunctive improvement in the appearance of skin laxity.
5
Image /page/5/Picture/0 description: The image shows the logo for "bios by Lumenis". The word "bios" is written in a modern, sans-serif font, with the letters connected in a flowing manner. Below "bios" is the text "by Lumenis", with the "Lumenis" part featuring a stylized "U" logo. The logo is clean and professional, suggesting a brand identity focused on technology and innovation.
Predicate Device Comparison
The purpose of the 510(k) submission is to add the abdominal circumference reduction indications for the NuEra Tight RF models that were last cleared under K210867. The subject, predicate and reference devices, as shown in Table 1 below, all share the same operating principle, which is the delivery of RF energy by skin-contact electrodes to heat the underlying tissues to a certain temperature for a time period to achieve the intended effect. The reference devices are cleared with a circumference reduction indication.
| TABLE 1. PREDICATE COMPARISON | ||||
|---|---|---|---|---|
| Feature | Subject Devices | Predicate Devices | Reference Device #1 | Reference Device #2 |
| Device name | NuEra Tight RF and | |||
| NuEra Tight RF Plus | NuEra Tight RF and | |||
| NuEra Tight RF Plus | truSculpt | SlimShape | ||
| Manufacturer | Bios s.r.l., Italy | Bios s.r.l., Italy | Cutera, USA | Syneron Medical Ltd., |
| Israel | ||||
| 510(k) | K223856 | K210867 | K162512 | K163415 |
| FDA Product Code | GEI, PBX | PBX | GEI, PBX | GEI |
| FDA Regulation | ||||
| Name | Electrosurgical Cutting and | |||
| Coagulation Device and | ||||
| Accessories | Electrosurgical Cutting and | |||
| Coagulation Device and | ||||
| Accessories | Electrosurgical Cutting and | |||
| Coagulation Device and | ||||
| Accessories | Electrosurgical Cutting | |||
| and Coagulation Device | ||||
| and Accessories | ||||
| FDA Regulation | ||||
| Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Operating | ||||
| Principle | Identical to Predicate | Radio frequency energy | ||
| delivered to the tissue to | ||||
| induce heat and increase the | ||||
| temperature of the treated | ||||
| area for therapeutic | ||||
| purposes | Radio frequency energy | |||
| delivered to the tissue to | ||||
| induce heat and increase the | ||||
| temperature of the treated | ||||
| area for therapeutic | ||||
| purposes. | Radio frequency energy | |||
| delivered to the tissue to | ||||
| induce heat and increase | ||||
| the temperature of the | ||||
| treated area and | ||||
| concomitant vacuum | ||||
| suction of the treated area. | ||||
| Indications for use | The NuEra Tight RF and | |||
| NuEra Tight RF Plus are | ||||
| intended: |
-
to provide topical heating
for the purpose of elevating
tissue temperature for the
treatment of selected
medical conditions such as
temporary relief of pain,
muscle spasms, and
increase in local circulation. -
to provide, with a massage
device, a temporary
reduction in the appearance
of cellulite. | NuEra Tight RF Family is
intended: -
to provide topical heating
for the purpose of elevating
tissue temperature for the
treatment of selected
medical conditions such as
temporary relief of pain,
muscle spasms, and
increase in local circulation. -
to provide, with a massage
device, a temporary
reduction in the appearance
of cellulite. | -truSculpt RF energy is
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. -
truSculpt massage device is
intended to provide a
temporary reduction in the
appearance of cellulite | Does not have these
indications. |
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Image /page/6/Picture/0 description: The image shows the logo for "bios by Lumenis". The word "bios" is written in a sans-serif font, with the letters in a dark blue color. Below the word "bios", the words "by Lumenis" are written in a smaller font size. The "Lumenis" part of the logo is also in dark blue, and there is a stylized "L" symbol next to it.
| TABLE 1. PREDICATE COMPARISON | ||||
|---|---|---|---|---|
| Feature | Subject Devices | Predicate Devices | Reference Device #1 | Reference Device #2 |
| Device name | NuEra Tight RF and | |||
| NuEra Tight RF Plus | NuEra Tight RF and | |||
| NuEra Tight RF Plus | truSculpt | SlimShape | ||
| - to provide, via heat- | ||||
| induced lipolysis at 1 and 2 | ||||
| MHz, abdominal | ||||
| circumference reduction | ||||
| with adjunctive | ||||
| improvement in the | ||||
| appearance of skin laxity. | Do not have this proposed | |||
| indication. | -2 MHz setting for the 40 | |||
| cm² handpiece is indicated | ||||
| for temporary reduction in | ||||
| circumference of the | ||||
| abdomen. | The SlimShape System is | |||
| indicated for non-invasive | ||||
| lipolysis (breakdown of | ||||
| fat) of the abdomen. The | ||||
| device is indicated for | ||||
| reduction in circumference | ||||
| of the abdomen. | ||||
| RF Frequencies | 470 kHz; 1 MHz; 2 MHz; | |||
| 4MHz; 6 MHz. | ||||
| For the proposed additional | ||||
| abdominal circumference | ||||
| reduction indication: 1 and | ||||
| 2 MHz | 470 kHz; 1 MHz; 2 MHz; | |||
| 4MHz; 6 MHz | 2 MHz | 1 MHz | ||
| RF output power | Max 250 W | Max 250 W | Max 300 W | Not Provided in 510(k) |
| Summary | ||||
| Temperature | ||||
| Monitoring | Yes | Yes | Yes | Yes |
| Electrodes | Capacitive electrodes of | |||
| 20, 30, 40, 40+massage, 60, | ||||
| 70, 80, and 100 mm in | ||||
| diameter. | Capacitive electrodes of | |||
| 20, 30, 40, 40+massage, 60, | ||||
| 70, 80, and 100 mm in | ||||
| diameter | Capacitive electrode of 40 | |||
| cm² area | Not described | |||
| How Used | Electrode is manually and | |||
| continuously moved over | ||||
| the treated area by the | ||||
| operator to maintain the | ||||
| specified temperature of the | ||||
| treated tissue over the | ||||
| specified duration. | Electrode is manually and | |||
| continuously moved over | ||||
| the treated area by the | ||||
| operator to maintain the | ||||
| specified temperature of the | ||||
| treated tissue over the | ||||
| specified duration. | Electrode is manually and | |||
| continuously moved over | ||||
| the treated area by the | ||||
| operator to maintain the | ||||
| specified temperature of the | ||||
| treated tissue over the | ||||
| specified duration. | SlimShape is described as | |||
| follows, | ||||
| "the SlimShape Applicator | ||||
| Belt incorporates an array | ||||
| of vacuum cavities; each | ||||
| cavity includes a pair of | ||||
| RF electrodes and a | ||||
| suction pad." | ||||
| Prescription use | Rx only | Rx only | Rx only | Rx only |
| Clinical data to | ||||
| support the | ||||
| abdominal | ||||
| circumference | ||||
| reduction | ||||
| indication | NCT04406935 | Not applicable | NCT02873104 | NCT02999763 |
Performance Bench Testing
Bench testing to the following standards were repeated to confirm that the devices continue to meet their specifications:
- . IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; A2:2021Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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Image /page/7/Picture/0 description: The image shows the logo for "bios by Lumenis". The word "bios" is written in a modern, sans-serif font, with the letters in a dark blue color. Below "bios" is the text "by Lumenis", with the "Lumenis" part of the text being in a smaller font size. To the left of "Lumenis" is a small, stylized "U" shape, also in dark blue.
- EN 60601-1-2:2015 Medical electrical equipment General requirements for basic . safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements and tests
No performance bench testing of the NuEra Tight RF models was conducted specifically for the additional circumference reduction indications because no device changes were needed to support this additional indication.
Performance Clinical Testing
A clinical study was performed to demonstrate the safety and effectiveness of the NuEra Tight RF Models for the proposed additional circumference reduction indications.
The study endpoints were as follows:
Primary Effectiveness Endpoint: Change in mean circumferential measurement at 12 weeks post last treatment compared to baseline within each treatment group.
Secondary Effectiveness Endpoints:
- . Change in skin laxity compared to baseline at 4 and 12 weeks post last treatment.
- Aesthetic improvement compared to baseline at 4 and 12 weeks post last treatment.
Safety Endpoints:
- . Subject Discomfort and Pain Levels during Treatment.
- Incidence and severity of device related adverse events during the study period. .
The study was a multi-arm, prospective, randomized, and multi-center. Initially, three arms were included in the study design:
- . Arm 1: NuEra treatment using 470 kHz
- . Arm 2: NuEra treatment using 1 MHz
- Arm 3: NuEra treatment using 2 MHz
An equal 1:1:1 randomization allocation was planned. However, due to the COVID-19 pandemic that led to restrictions on non-essential medical procedures, quarantine, or reticence by subjects, the study experienced a high drop-rate. To maintain study power due to the availability of subjects during the COVID-19 pandemic and resource constraints, the sponsor revised the protocol to stop enrolling Arm 1. The second phase of the study randomized the remaining participants into only two arms: 1 MHz treatment or 2 MHz treatment, with a similar 1:1 randomized equal allocation. As each arm will be analyzed separately, the statistical power for each arm was unaffected.
The treatment regimen in the revised protocol remained the same as in the original protocol. Each subject received 4 treatments at 1 week intervals. Follow-up evaluations took place at 4 weeks (Follow-up 1) and 12 weeks (Follow-up 2) after the last treatment.
The results of the study were as follows:
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Image /page/8/Picture/0 description: The image shows the logo for "bios by Lumenis". The word "bios" is written in a modern, sans-serif font, with the letters in a dark blue color. Below the word "bios", the phrase "by Lumenis" is written in a smaller font size. The "L" in "Lumenis" is stylized with a blue circle around it.
For the 82 enrolled and randomized subjects:
- mean age of 46.8±11.3 years, with a range of 21.7-65.4 years; ●
- . seventy-two (72) females and 10 males;
- self-identified to be: White (79%); Other (10%); Black or African American (6%); or ● Asian (5%), and to be of Hispanic or Latino ethnicity (13%); and,
- mean circumference of 85.93±8.51 cm, with a range of 67.93-104.6 cm.
Due to the COVID-19 pandemic, 18 subjects did not complete at least 3 of 4 treatment sessions. Also, 32 subjects had a major protocol deviation, through either not having the second followup visit (13 subjects) or had the second follow-up visit more than 4 weeks late (19 subjects).
The data supporting the additional indications are from subjects who completed at least 3 of the 4 treatment sessions. They include:
Primary Effectiveness Endpoint: The mean change (reduction) from baseline in waist circumference at 12 weeks follow up was found to be statistically significant in the 1 MHz (n=23) and 2 MHz (n=18) groups:
Secondarv Effectiveness Endpoints:
-
. Skin laxity: Blinded assessors evaluated before/after pictures and identified improvement in skin laxity in a majority of subjects at the 4 and 12 week follow up visitsAesthetic appearance: Investigators and subjects were asked to assess aesthetic appearance after each visit (GAIS score). The majority in each group reported improvement in appearance.
In addition, blinded reviewers were asked to identify which photos of subjects (per visit and treatment arm in subjects who completed the study course and appeared for all followup visits) were 'before treatment' and 'after treatment' pictures. The results were that most pictures were correctly identified by the blinded reviewers. Safety: -
The median VAS Score was 0, with 50% of the subjects reported no pain or discomfort ● during any of the treatments and the average pain for all treatment arms was 1.6 (lowlevel of pain).
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. One subject from the 2 MHz arm had a mild burn that was deemed related to the procedure, the adverse event (AE) resolved with no action taken (1/276 treatments, 0.3%).
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There were 2 AEs considered by the investigators as possibly related to the device or the procedure (diarrhea and back pain). The events were mild and resolved with no action.
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None of the AEs was considered serious. ●
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Conclusion
The proposed additional indication for the subject devices has already been cleared for the reference devices at treatment frequencies of 1 MHz and 2 MHz and using the same RF induction technology as the subject devices, which show that the proposed additional indication does not present a new intended use for RF induction devices. The provided clinical data for the subject devices, operating at 1 MHz frequencies, demonstrate that they are safe and effective for the proposed additional abdominal circumference reduction indication. The subject devices have the identical intended use and technological characteristics as their predicates, and the proposed additional indication does not create a new intended use or raise a new safety or effectiveness question. Thus, the subject devices are substantially equivalent to the predicate devices.