(152 days)
No
The description focuses on RF energy delivery, temperature feedback, and physician control, with no mention of AI/ML terms or capabilities.
No
A therapeutic device is used to treat or alleviate a disease or medical condition. This device is indicated to improve the appearance of facial wrinkles and cellulite, which are aesthetic concerns rather than medical conditions.
No
The device is used for electrocoagulation and hemostasis in dermatologic and general surgical procedures, specifically for treating facial wrinkles and improving the appearance of cellulite. It delivers bipolar RF energy to the dermal layers for therapeutic effect, not for diagnosing conditions.
No
The device description clearly states it is comprised of hardware components including a console with an RF generator, treatment applicators, and electrode cartridges, in addition to a graphical user interface which would involve software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electrocoagulation and hemostasis," specifically for treating facial wrinkles and improving the appearance of cellulite. This involves direct treatment of the patient's body.
- Device Description: The device delivers radiofrequency energy into the dermal layers of the skin. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for cosmetic and surgical procedures.
N/A
Intended Use / Indications for Use
The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by longterm clinical data (6 months).
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
The Profound System is comprised of the following components: a re-usable console containing a radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial wrinkles, thighs
Indicated Patient Age Range
Healthy females ages 25 to 60 years of age
Intended User / Care Setting
Physician
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)
Study Design: Prospective, single-arm, self-controlled, multicenter clinical study
Sample size: 50 patients (100 thighs) were treated across 4 U.S. sites.
Key Results:
Primary Endpoint Met: 94% (79/84) of the treated thighs based on observed data had an improvement in cellulite appearance per blinded review. 88% (37/42) of the treated subjects showed improvement in both thighs in dimples and/or undulation at 3 months follow up.
Secondary Endpoint: Improvement in cellulite appearance was maintained at 6 months follow up; 93% (78/84) of the treated thighs (per-subject success (both thighs) of 86%) showed improvement in cellulite appearance at 6 months post-treatment compared to baseline based on blinded review. Investigator cellulite reduction assessment results demonstrated progressively improved treatment effects for the large majority of thighs at 3 and 6 months following treatment. Cellulite improvement per the Nurnberger-Muller scale also demonstrated increasing levels of improvement throughout the study. Nearly all of the thighs showed improvement at 1 month following treatment and all thighs showed improvement at both 3 and 6 months following treatment. Investigator satisfaction increased gradually along the study course and was demonstrated for the majority of the subjects at 3 and 6 month follow up. Subject improvement results showed moderate to excellent reduction for most of the thighs at 3 and 6 month follow up. Subject satisfaction was reported by a majority of subjects at 3 and 6 month follow-up visits.
Safety Results: Of the 50 total subjects, only 3 subjects reported a total of 3 adverse events. None were serious and each event resolved during the study. Anticipated treatment-associated responses experienced during the first week following treatment were also reported. None of the immediate responses were observed at the next visit (i.e., 1 month follow-up visit).
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.
Syneron-Candela's Profound System (K082391, K080145), Viora Ltd.'s V10 System (K150035)
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.
Cynosure's Cellulaze Laser (K123407)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, with flowing lines beneath them, resembling a bird or a wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2016
Syneron Candela Corporation % Janice Hogan Regulatory Counsel Hogan Lovells Us Llp 1835 Market Street 29th Floor Philadelphia, Pennsylvania 19103
Re: K161043
Trade/Device Name: Profound 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: August 15, 2016 Received: August 15, 2016
Dear Janice Hogan:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S.Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last paqe
510(k) Number (if known)
Device Name
Profound System
Indications for Use (Describe)
The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary Profound System
| Submitted by: | Syneron Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ruthie Amir
Global Vice President of Clinical, Regulatory, and Education
Tel: 508-358-7400 x330
Fax: 508-358-5602 |
| Submission Correspondent: | Janice Hogan
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philadelphia, PA 19103
Tel: (267) 675-4600
Fax: (267) 675-4601
janice.hogan@hoganlovells.com |
| Date prepared: | September 12, 2016 |
| Trade Name: | Profound System |
| Common Name: | Electrosurgical unit and accessories |
| Classification: | Class II per 21 C.F.R. § 878.4400 – Electrosurgical cutting and
coagulation device and accessories
Product Code PBX, GEI |
| Predicate Devices: | Primary Predicate Devices
Syneron-Candela's Profound System (K082391, K080145)
Viora Ltd.'s V10 System (K150035)
Reference Predicate Device
Cynosure's Cellulaze Laser (K123407) |
Intended Use / Indications for Use:
The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25° Dermal handpiece and cartridge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by longterm clinical data (6 months).
Device Description:
The Profound System is comprised of the following components: a re-usable console containing a
4
radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.
Technoloqical Characteristics:
The Profound System has similar technological characteristics as its predicates. The primary purpose of this submission is to expand the Profound's indications for use to include long-term improvement in the appearance of cellulite.
The Profound design and components are very similar to those previously cleared. Specifically, the cleared 25° Dermal handpiece and associated electrode cartridge have remained essentially the same, with minor hardware and software changes. The company has also added an option for the physician to use a 75° SubQ handpiece and associated electrode cartridge. The modified device is based on the same principles of operation, i.e., thermal heating. The RF frequency and maximum output voltage per channel are the same as for the cleared Profound System. Same as the previously cleared Profound, the system has an electrically powered console with a graphical user interface through which the physician pre-sets treatment parameters (as appropriate for each patient) and obtains real-time feedback regarding ongoing treatment. Minor software changes have been made and the updated software has been subjected to verification and validation. The technological differences compared to the predicates do not raise any different types of safety or effectiveness questions, because the modified device operates in the same manner and the treatment parameters are the same as or within the range of the predicates.
Summary of Substantial Equivalence:
The subject Profound System has the same intended use and similar indications for use as its predicates. The indications of the subject device are the same as those of the predicate. K082391. except for the proposed additional indication for use: "...improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months)." The newly added indications for use, while not the same, is similar to the Viora V10 System predicate which is cleared for "...Temporary reduction in the appearance of cellulite." Moreover, the newly added indications for use is similar to the reference predicate device, Cellulaze (K123407), indications for use, which is as follows: "Cynosure Cellulaze ™ laser is intended for the improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation)."
The subiect device and the primary predicate devices are radio frequency (RF) based electrosurgical devices. The subject device has similar components and the same energy output as the Profound primary predicate, and minor design changes to the previously cleared console and 25° handpiece do not impact device performance. The added 75º cartridge and associated handpiece have similar technological characteristics as the previously cleared cartridge and handpiece.
The similarities and differences in terms of indications for use and technological characteristics between the subject and predicate devices are summarized in the below side comparison table. To address the differences in the indications for use and technological parameters, a clinical study was performed, as described below in the Performance Data section of this 510(k) Summary.
5
The clinical data support substantial equivalence of the Profound compared to its predicate devices. The technological differences have also been evaluated in bench testing. Minor software changes to accommodate the expanded technological features have been verified and validated.
| Product | Syneron-Candela Corp.'s
Profound System
(K161043) | Primaeva Medical, Inc.'s
Miratone System
(K082391, K080145) | Viora Ltd.'s V10 System
(K150035) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Profound System is
indicated for use in
dermatologic and general
surgical procedures for
electrocoagulation and
hemostasis. Specifically,
the 25° Dermal handpiece
and cartridge are used for
percutaneous treatment of
facial wrinkles, and the 75°
SubQ handpiece and
cartridge are used to
improve the appearance of
cellulite in patients with
Fitzpatrick skin types I-III as
supported by long-term
clinical data (6 months). | The Primaeva Medical
Miratone System is indicated
for use in dermatologic and
general surgical procedures
for electrocoagulation and
hemostasis, and the
percutaneous treatment of
facial wrinkles. | The Viora V10 system is
intended for dermatological
procedures. The V-Form
Handpiece, with Body-
Contour (BC) and Facial-
Contour (FC) applicators,
is indicated for delivering
non-thermal RF combined
with massage:
• relief of minor muscle
aches and pain, relief of
muscle spasm,
temporary improvement
of local blood
circulation and
• Temporary reduction in
the appearance of
cellulite. |
| Product Code | PBX, GEI | GEI | PBX, ISA |
| Energy Type | Bipolar fractionated RF | Bipolar fractionated RF | Bipolar RF, Vacuum |
| RF Frequency | 460 +/- 5kHz | 460 +/- 5kHz | 0.8, 1.7, or 2.45 MHz, or
combination of all 3
frequencies |
| Components | • RF generator with user
interface
• Reusable electrode
insertion
device/applicators (25°
with cooling plate and 75°)
• Single patient use,
disposable, 25° and 75°
electrode cartridges | • RF generator with user
interface
• Cooler controller and
handpiece/applicator
• Reusable electrode
insertion device/applicator
• Single patient use
disposable, 25° electrode
cartridge. | • Console (RF generator,
user interface, etc.)
• Applicators (with cable,
connector to console,
and vacuum pump; 2
available for cellulite
indication) |
| Maximum Output
Voltage | 84 VRMS | 84 VRMS | Not specified |
| Channels | 25° applicator: 5
independent channels
(electrode pairs)
75° applicator: 7
independent channels | 25° applicator: 5
independent channels
(electrode pairs) | Multi-channel;
6 electrodes (V-Form
handpiece) |
| Target Temperature
Range | 65-75°C +/- 1°C increments | 65-75°C +/- 1°C increments | Not specified |
| Treatment Area
Width | 14 mm for the 25° mode (5
pairs)
20 mm for the 75° mode (7
pairs) | 14 mm (5 pairs) | BC applicator: 97 x 83 mm
FC applicator: 0-24 mm |
| User Interface | GUI - color LCD display | GUI - color LCD display | Display unit |
| System
Dimensions | 125 x 46.5 x 44.5 cm /
29.5 x 18.5 x 17.5 inches | 125 x 46.5 x 44.5 cm /
29.5 x 18.5 x 17.5 inches | 45 x 35 x 40 cm |
| Product | Syneron-Candela Corp.'s
Profound System
(K161043) | Primaeva Medical, Inc.'s
Miratone System
(K082391, K080145) | Viora Ltd.'s V10 System
(K150035) |
| Electrical
Requirements | 100-240 VAC; 2.5 A; 50-60 Hz; single phase | 100-240 VAC; 2.5 A; 50-60 Hz; single phase | 90-264 VAC; 50-60 Hz;
single phase |
| Sterilization | Cartridges are sterilized | Cartridges are sterilized | Not specified |
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In summary, minor differences between the subject Profound and the predicates do not present different types of safety or effectiveness questions, since the Profound's energy parameters are similar to or within the range of the predicates and the device operates in the same manner and for the same general intended use as the primary predicates. Further, the device's safety and performance have been confirmed by results of both clinical and non-clinical investigations. Therefore, the subject Profound System has the same intended use and similar indications for use. technological characteristics, and principles of operation as the predicate devices.
Performance Data:
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) testing for the modified Profound System was conducted by an independent test laboratory in accordance with the applicable standards (IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance. EN 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, and IEC 60601-2-2. 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). The Profound System was determined to be in conformance with these standards.
Biocompatibility: The biocompatibility of the Profound device has been established per ISO 10993 guidelines as well as comparison to previously cleared Syneron applicators using the same chrome plating for the same type and duration of patient contact.
Software: Software verification and validation testing was conducted and results were found acceptable for software release.
Bench Testing: Performance testing on the RF generator, 25º Dermal handpiece, and 25º Dermal cartridge was previously conducted and confirmed device performance. Bench testing performed on the new 75º SubQ handpiece and cartridge demonstrated that the modified device performs as intended and device outputs met specifications.
Clinical Data: In support of this 510(k), a single arm, self-controlled, multi-center study was conducted to evaluate the safety and effectiveness of the Profound for improving cellulite appearance. The clinical study evaluated 50 treated subjects (100 thighs), all females, across all skin types. Mean age was 44 years and the majority of the subjects were Caucasian. Data demonstrated that the Profound performs as intended when used for this indication. Treatment with the Profound did not lead to any device-related serious adverse events. The mean pain level reported (3.74/10) reflects patient comfort when the procedure is performed as indicated, i.e., with tumescent anesthesia and cold air. Anticipated treatment responses reported immediately after the procedure (e.g., erythema, edema) all completely resolved without medical intervention. The study met the primary endpoint, where 94% of treated thighs demonstrated improvement in cellulite
7
appearance as assessed by blinded review at 3 months following treatment when considering improvement in dimples and/or undulation irregularities. When considering improvement in each cellulite feature separately, 86% of the treated thighs with dimples at baseline) showed improvement in dimples, and 76% of the thighs had undulation at baseline) showed improvement in undulation irregularities. Per subject results were 88% (37/42) of the treated subjects showed improvement in both thighs in dimples and/or undulation at 3 months follow up. When considering each cellulite feature separately, 71% of the treated subjects showed improvement in dimples in both thighs, and 64% showed improvement in undulation irreqularities in both thighs.
Further, additional assessments of treatment effectiveness were also favorable. These included blinded review at 6 months post-treatment, where improvement in cellulite appearance was maintained at 6 months follow up; 93% (78/84) of the treated thighs (per-subject success (both thighs) of 86%) showed improvement in cellulite appearance at 6 months post-treatment compared to baseline based on blinded review. In addition, assessments also included, openlabel assessments by investigators and patients of the severity of cellulitic features, overall improvement in cellulite appearance, and satisfaction with treatment at 1, 3, and 6 months following treatment. Therefore, the study results for the subject device did not present any different types of safety or effectiveness questions as compared to the predicates. The study design and results are summarized in the table below.
| Study
| Design | Prospective, single-arm, self-controlled, multicenter clinical study |
|---|---|
| Sample size | 50 patients (100 thighs) were treated across 4 U.S. sites. |
| Principal | |
| Eligibility | |
| Criteria | Seeking treatment of cellulite in the upper thighs areas Presenting with cellulite stage II or III as graded using the Nurnberger- |
| Muller scale classification Healthy females ages 25 to 60 years of age Willing to receive the proposed Profound treatment and comply with the | |
| follow-up protocol | |
| Follow up | |
| intervals | 4 follow-up visits: 1 week, 1 month, 3 months and 6 months following treatment. |
| Endpoints | Primary: The study primary endpoint was achieved when 80% of thighs showed |
| at least 1 point level of improvement in the appearance of cellulite at 3 month | |
| follow-up visit relative to baseline photos based on blinded review. |
Secondary: Cellulite appearance improvement by blinded evaluators at 6 months
post treatment visit. Cellulite appearance improvement by study investigators. Investigator improvement and satisfaction assessments. Subject improvement and satisfaction assessments. |
8
| Effectiveness
Results | Primary: Met endpoint; 94% (79/84) of the treated thighs based on observed
data had an improvement in cellulite appearance per blinded review. 88%
(37/42) of the treated subjects showed improvement in both thighs in dimples
and/or undulation at 3 months follow up. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Secondary:
Improvement in cellulite appearance was maintained at 6 months follow
up; 93% (78/84) of the treated thighs (per-subject success (both thighs)
of 86%) showed improvement in cellulite appearance at 6 months post-
treatment compared to baseline based on blinded review.
Investigator cellulite reduction assessment results demonstrated
progressively improved treatment effects for the large majority of thighs
at 3 and 6 months following treatment.
Cellulite improvement per the Nurnberger-Muller scale also
demonstrated increasing levels of improvement throughout the study
(majority of the thighs showed improvement at 3 and 6 months following
treatment).
Nearly all of the thighs showed improvement at 1 month following
treatment and all thighs showed improvement at both 3 and 6 months
following treatment.
Investigator satisfaction increased gradually along the study course and
was demonstrated for the majority of the subjects at 3 and 6 month
follow up.
Subject improvement results showed moderate to excellent reduction for
most of the thighs at 3 and 6 month follow up.
Subject satisfaction was reported by a majority of subjects at 3 and 6
month follow-up visits. |
| Safety
Results | Of the 50 total subjects, only 3 subjects reported a total of 3 adverse events.
None were serious and each event resolved during the study. Anticipated
treatment-associated responses experienced during the first week following
treatment were also reported. None of the immediate responses were observed
at the next visit (i.e., 1 month follow-up visit). |
The distribution of numbers of insertions in the study suggested that most treatments were covered by a range of up to 300 insertions per thigh, or up to a maximum treatment density of 1.333. No clear dose-response relationship was observed, and treatment beyond these levels has not been shown to improve outcomes and is not recommended.
Conclusions:
Testing of the Profound System demonstrated that the device performs as intended with a favorable safety profile. The non-clinical data further support device safety. Verification and validation testing of the modified software demonstrates that the device performs as intended. Thus, the Profound System is substantially equivalent to the predicate devices.