(239 days)
Not Found
No
The summary describes a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation technologies. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on thermal testing and software verification/validation, not on the performance of an AI/ML algorithm.
Yes
Explanation: The device is intended for various medical purposes, including electrocoagulation and hemostasis (PiXel8-RF), non-invasive lipolysis to achieve a desired aesthetic effect (BodySculp), and relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles, and maintaining or increasing range of motion (BodyTone), all of which are considered therapeutic applications.
No
The device descriptions and intended uses do not mention any diagnostic functions. All descriptions relate to therapeutic or aesthetic procedures, such as electrocoagulation, hemostasis, lipolysis, muscle stimulation, and pain relief.
No
The device description clearly states it is a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation technologies into a single console with three handpieces. This involves significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Gladiator System's Intended Use: The intended uses described for the Gladiator system and its handpieces are all related to direct treatment or physical effects on the body. These include:
- Electrocoagulation and hemostasis (PiXel8-RF)
- Non-invasive lipolysis (Bodysculp)
- Muscle stimulation for various therapeutic purposes (Body Tone)
- Lack of Specimen Analysis: There is no mention of the Gladiator system collecting, preparing, or analyzing any specimens from the human body for diagnostic purposes.
The Gladiator system is a therapeutic device that applies energy (RF, laser, electrical stimulation) directly to the patient's body for various medical and aesthetic purposes. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Gladiator system contains three handpieces, each of which has its own indications for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OUH, GEX, IMG
Device Description
The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:
- PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
- . BodySculp - a low level laser
- . BodyTone (previously called Futura Pro) – an electronic muscle stimulator
The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
flank and abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
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
Thermal testing:
Sample size: Not Specified
Data source: ex vivo kidney, liver, and skin tissues
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Study Type: Verification and validation activities. Testing included compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, and EN ISO 14971.
Sample Size: Not Specified.
Key results: "successfully completed and establish that the Gladiator control unit performs as intended."
Thermal Testing:
Study Type: Comparative thermal testing.
Sample Size: Three tissue types (ex vivo kidney, liver, and skin).
Key results: "Thermal damage profiles for the Test and Predicate Devices were in close proximity in all test tissues. The Test Device showed somewhat milder thermal damage (moderately smaller CMZs) in treated tissues, which indicates a safer nature of the new generation PiXel8. At the same time, the study demonstrated the ability of the Test Device to achieve consistent thermal damage profiles in line with the target treatment and were comparable to the profiles produced by the Predicate Device. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect."
Software verification and validation testing:
Study Type: Verification and validation testing.
Sample Size: Not Specified.
Key Results: "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."
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2024
Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Homewood, Alabama 35209
Re: K233099
Trade/Device Name: Gladiator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, OUH, GEX, IMG Dated: April 19, 2024 Received: April 19, 2024
Dear Mark Rohrer:
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" (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).
1
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.
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 medical devices and radiation-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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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 H. Chen - S Digitally signed by Long H.Chen-S
Digitally signed Date: 2024.05.22 13:54:06 -04'00'
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
2
Indications for Use
510(k) Number (if known) K233099
Device Name Gladiator
Indications for Use (Describe)
The Gladiator system contains three handpieces, each of which has its own indications for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
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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3
| Applicant
Address | Rohrer Aesthetics
105 Citation Court
Homewood, Alabama 35209 |
|---------------------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person | Mark Rohrer |
| Contact Information | President, Rohrer Aesthetic
205-940-2200
mrohrer@rohreraesthetics.com |
| Preparation Date | May 22, 2024 |
| Device Trade Name | Gladiator |
| Classification Name | Electrosurgical Cutting and Coagulation Device and
Accessories
Powered Laser Surgical System |
| Regulation Number | 878.4400, 878.5400, 878,5860 |
| Product Code | GEI, OUH, PKT, IMG |
| Regulatory Class | II |
| Legally Marketed Predicate
Devices | Pinxel-RF system (K180654)
BodySculpt (K212331)
Futura Pro (K102524) |
Device Description:
The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:
- PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
- . BodySculp - a low level laser
- . BodyTone (previously called Futura Pro) – an electronic muscle stimulator
The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
Indications for use:
Each of the handpieces has its own indication for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
4
The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The BodyTone handpiece is intended for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
| Proposed Device
RF Microneedling Handpiece | Pinxel-RF System
K180654 | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| The RF Microneedling handpiece is
intended for use in dermatologic and
general surgical procedures for
electrocoagulation and hemostasis. | The RF Microneedling handpiece is
intended for use in dermatologic and
general surgical procedures for
electrocoagulation and hemostasis. | Same |
| Proposed Device
BodySculp Handpiece | BodySculp
K212331 | Comparison |
| The Bodysculp laser lipolysis system is
intended for non-invasive lipolysis of
the flank and abdomen to achieve
disruption of adipocyte cells intended
for non-invasive aesthetic use to
achieve a desired aesthetic affect. This
treatment is intended for individuals
with a Body Mass Index (BMI) of 30 or
less. | The Bodysculp laser lipolysis system is
intended for non-invasive lipolysis of
the flank and abdomen to achieve
disruption of adipocyte cells intended
for non-invasive aesthetic use to
achieve a desired aesthetic affect. This
treatment is intended for individuals
with a Body Mass Index (BMI) of 30 or
less. | Same |
| Propose Device
BodyTone Handpiece | Futura Pro
K101524 | Comparison |
| The BodyTone handpiece is intended
for Relaxation of muscle spasms,
Prevention or retardation of disuse
atrophy, Increasing local blood
circulation, Muscle re-education,
Immediate post-surgical stimulation of
calf muscles to prevent venous
thrombosis, Maintaining or increasing
range of motion. Powered muscle
stimulators should only be used under | The BodyTone handpiece is intended
for Relaxation of muscle spasms,
Prevention or retardation of disuse
atrophy, Increasing local blood
circulation, Muscle re-education,
Immediate post-surgical stimulation of
calf muscles to prevent venous
thrombosis, Maintaining or increasing
range of motion. Powered muscle
stimulators should only be used under | Same |
Indications for use comparison
5
| medical supervision for adjunctive
therapy for the treatment of medical | medical supervision for adjunctive
therapy for the treatment of medical | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------|--|
| diseases and conditions. | diseases and conditions. | |
Technical Specifications Comparison
RF Handpiece
| | Proposed Device
Gladiator | Predicate 1
PINXEL-RF system
(K180654) | Comparison |
|-------------------------------------------|---------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Type | Bipolar Radiofrequency | Bipolar Radiofrequency | Same |
| RF Frequency | 4MHz | 2MHz | Different. Thermal testing
shows that the performance
of the two devices is
substantially equivalent. |
| Max Power | Max 25W @ 500ohm | Max 25W @ 500ohm | Same |
| Total Power
delivered per
treatment | 25W | 25W | Same |
| Power per
pin | 25W | 25W | Same |
| RF Duration | 50ms-950ms | 50ms-950ms | Same |
| Tips | 25, 49 and 64 pin
microneedle electrodes | 25 and 64 pin microneedle
electrodes | Addition of one new
electrode with 49 pins. The
electrode is mid-way
between the sizing of the
others and does not impact
the needle depth. |
| Needle Insert
Depth | 0.5-3.5mm | 0.5-3.5mm | Same |
BodySculp Handpiece
| | Proposed Device
BodySculp Handpiece | BodySculp
K212331 | Comparison |
|---------------------|----------------------------------------|----------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Same |
| Wavelength | 1060nm | 1060nm | Same |
| Lipolysis
method | Heat-assisted | Heat-assisted | Same |
6
| | Proposed Device
BodySculp Handpiece | BodySculp
K212331 | Comparison |
|------------------|-----------------------------------------------------------|-----------------------------------------------------------|------------|
| Spot Size | 4 × 8 cm2 (A single
applicator
of four applicators) | 4 × 8 cm2 (A single
applicator
of four applicators) | Same |
| Peak Power | 50W(per applicator) | 50W(per applicator) | Same |
| Power
Density | Up to 0.7-1.7W/ cm2 | Up to 0.7-1.7W/ cm2 | Same |
| Pulse width | CW | CW | Same |
| Power
supply | AC100-240V/50-
60Hz(customizable ) | AC100-240V/50-
60Hz(customizable ) | Same |
| Cooling | Contact Cooling | Contact Cooling | Same |
Bodytone Handpiece
| Item | Description | Futura Pro | Comparison |
|---|---|---|---|
| (K102524) | |||
| Number of Output | |||
| Modes | Two - Biphasic / | ||
| Monophasic | Two - Biphasic / | ||
| Monophasic | Same | ||
| Number of Output | |||
| Channels | 10 channels | 10 channels | Same |
| Maximum RMS O/P | |||
| Current | 16.2 mA,m,@500 | ||
| ohm | 16.2 mA,m,@500 ohm | Same | |
| Minimum electrode size | 7.0 cm dia. (38.5 cm') | 7.0 cm dia. (38.5 cm') | Same |
| Maximum Current | |||
| Densitv IRMS\ | 0.421 mA/cm'@ 500 | ||
| ohm | 0.421 mA/cm'@ 500 | ||
| ohm | Same | ||
| Maximum RMS | |||
| Power Density | 3.42 mW/cm' @ 500 | ||
| ohm | 3.42 mW/cm' @ 500 | ||
| ohm | Same | ||
| pk current into 500 | |||
| Ohms | 120mA | 120mA | Same |
| Max charge/Pulse | 27.2 μC | 27.2 μC | Same |
| pk voltage, no load | 80 Volts | 80 Volts | Same |
7
| Maximum frequency | 100 Hz | 100 Hz | Same |
|---|---|---|---|
| Max Pulse width | 300 us | 300 us | Same |
Substantial Equivalence Discussion
The subject device, the Gladiator, is identical in indications for user and nearly identical in technical specifications to its predicate devices. The sole changes to the device functionality, the RF frequency and addition of one new RF microneedling tip do not have an impact on the safety or efficacy of the device. Thermal testing of the device at the new 4Mhz RF frequency shows that the change raises no new concerns of safety and efficacy.
Performance Testing
Verification and validation activities were successfully completed and establish that the Gladiator control unit performs as intended. Testing included the following:
- IEC 60601-1:2005 + Corr.1:2006 + A1:2012; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- . IEC 60601-1-2:2014 + A1:2020; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests;
- . IEC 60601-2-2:2017; 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 62304:2006+A1:2015; Medical Device - Software Life Cycle Processes;
- EN ISO 14971:2019+A11:2021; Medical Devices Application Of Risk Management To . Medical Devices
Thermal Testing
The following summarizes the thermal testing conducted to compare the new frequency of 4Mhz to the predicate's 2MHz frequency. Testing was conducted with 49-pin microneedling cartridges on three tissue types (ex vivo kidney, liver, and skin). Treatment settings included the three power levels: low (2.5 W), medium (7.5 W) and maximum (25 W), at a Pulse Width of 800 milliseconds (ms). Target penetration depth was 3.5 mm (e.g., max depth device delivers). Earlier generation PiXel8, operated on 2 MHz frequency, was used as the Predicate Device. The predicate was also equipped with the same microneedling cartridges as the Test Device and tested on all three types of tissue. Since the Predicate Device was used as a reference, it was tested for the worst cases only; e.g. maximum power level (25 W) and pulse width of 800 ms.
Thermal damage profiles for the Test and Predicate Devices were in close proximity in all test tissues. The Test Device showed somewhat milder thermal damage (moderately smaller CMZs) in treated tissues, which indicates a safer nature of the new generation PiXel8. At the same time, the study demonstrated the ability of the Test Device to achieve consistent thermal damage profiles in line with
8
the target treatment and were comparable to the profiles produced by the Predicate Device. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect.
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.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Biocompatibility -
PiXel8 RF Microneedling handpiece
The only parts of the device in contact with the patient are the sterile needles of the microneedle tips. Per ISO 10993-1, the tips are classified as a limited duration external communicating device. The tip comes in contact with tissue / bone / dentin. The tips are constructed of stainless steel with gold plating and do not include any coloring. The plastic housing of the handpiece is made of a Polycarbonate resin. No new biocompatibility testing is required for this submission because the materials and the manufacturing process are identical to the original PinXel-8 device (K180654).
BodySculp
The patient contacting materials of Bodysculp are Sapphire Glass, gold plating, PET and polyester. As defined in Appendix A: ISO 10993-1:2009 these materials would be categorized as surface device contact with intact skin for limited duration. This categorization would require the minimal tests recommended by 10993-1. However, the materials and processing are identical to those used in the predicate device and other previously cleared medical devices, thus do not require additional testing.
No new biocompatibility testing is required for this submission because the materials and the manufacturing process are identical to the original BodySculp device (K212331).
Bodytone
The patient contacting materials of Bodytone handpiece is Silicone. As defined in Appendix A: ISO 10993-1:2009 these materials would be categorized as surface device contact with intact skin for limited duration. This categorization would require the minimal tests recommended by 10993-1. However, the materials and manufacturing processes are identical to those used in the predicate device. In addition, the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of
9
medical devices - Part 1: Evaluation and testing within a risk management process" lists silicone as exempt from testing if it is used on intact skin with limited contact.
Discussion
The subject device, the Gladiator, is identical in indications and nearly identical in technical specifications to its predicate devices. The sole changes to the device functionality, the RF frequency and addition of one new mid-sized RF microneedling tip do not have an impact on the safety or efficacy of the device.
The testing conducted and above comparison of devices shows that the Gladiator is substantially equivalent to the predicate devices.