(147 days)
Not Found
No
The summary describes a device that delivers radio frequency and ultrasound energy based on user-selected settings and attached handpieces. There is no mention of AI or ML being used for decision-making, data analysis, or adaptive treatment. The device appears to operate based on pre-programmed parameters and user input.
Yes
The device's intended uses, such as "relief of minor muscle aches and pains," "relief of muscle spasm," "temporary improvement of local blood circulation," and "temporary reduction in the appearance of cellulite," directly address physiological conditions and aim to restore or modify body functions. The application of ultrasound for "non-invasive reduction in abdominal circumference" also falls under therapeutic intervention.
No
The device description and intended use indicate that it is used for aesthetic and therapeutic purposes (e.g., pain relief, reduction of cellulite, reduction in abdominal circumference) and does not mention any diagnostic functions or capabilities like detecting, identifying, or monitoring medical conditions.
No
The device description explicitly details hardware components such as a power source, control circuitry, applicator handpieces (RF and ultrasound), a piezo transducer, and a mechanical enclosure. It is a physical device that delivers energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Ultimate Contour device applies radio frequency and ultrasound energy directly to the patient's body (specifically the abdominal area) for therapeutic purposes (pain relief, muscle spasm relief, blood circulation improvement, cellulite reduction, and waist circumference reduction).
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from the patient.
The device is a therapeutic medical device that delivers energy externally to the body.
N/A
Intended Use / Indications for Use
- Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. 2) Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.
Product codes
PBX, OHV
Device Description
The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.
Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.
The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal area
Indicated Patient Age Range
18 or older
Intended User / Care Setting
Controlled medical office or practice
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
A clinical evaluation of the device on a representation of the intended population was performed in a single-site single-arm study. The study evaluated the safety and effectiveness of the device in waist circumference reduction. A total of 42 subjects completed the treatment regimen of the device with one week between each treatment, and 1-week follow ups. The safety analysis included all subjects who participated at any point during the course of the study. Effectiveness was gauged by determining if waist circumference reduction was achieved relative to a value identified as clinically meaningful, a value of at least 1 inch of waist circumference reduction of the treatment regimen. The clinically meaningful value was identified based on published studies utilizing other devices for the same purpose. Measurements were conducted prior to and after each treatment, and at the 1-week follow-up visits. Clinicians were blinded relative to measuring pre-treatment and post-treatment.
The study included subjects age 18 or older who met all inclusion criteria and none of the exclusion criteria. The majority of study subjects were Caucasian females. Mean age of the subjects was 42.8 years. Mean baseline waist circumference prior to the first treatment was measured at 40.95 inches, and an average initial BMI of 29.36. The primary effectiveness endpoint measured the difference between waist circumference prior to the first treatment with the device. The safety endpoint assessed all adverse events and serious adverse events occurring during the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Performance Testing, single-site single-arm study.
Sample Size: 42 subjects completed the treatment regimen.
Key Results: The study results for the primary endpoint demonstrated an average circumference reduction of 2.0 inches to the 4-week follow up visit, which was statistically significant compared to the target threshold of 1.0 inches (p=0.05). The greatest circumference reduction for this period was measured at 3.75 inches, and the least circumference reduction was measured at 0.75 inches. T-test and Kolmogorov-Smirnov tests demonstrated that the data can be considered normally distributed. Correlation analysis comparing the baseline measurements and 4-week follow-up measurements returned a correlation score of 0.9901. With all missing data imputed with a least-favorable regimen outcome (0.75 inch reduction), the effect of device treatment on circumference reduction remained greater than the 1.0 inch reduction threshold. The treatment was administered without anesthetic. 7 subjects reported a sensation of ringing or buzzing in the ears, which was substantial enough to cause 2 of the subjects to discontinue participation. Follow-up audiology assessment with these subjects identified no substantial or worsening audible capabilities. Most adverse events resolved within 1-2 days after the treatment. These included skin rash, changes in bowel movement, and changes in urine consistency. The events were either self-resolved with the use of over-the-counter products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
October 28, 2020
CAO Group, Inc. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084
Re: K201475
Trade/Device Name: Ultimate Contour, Ultimate Contour Mini Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, OHV Dated: July 7, 2020 Received: July 13, 2020
Dear Robert K. Larsen:
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,
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201475
Device Name
Ultimate Contour, Ultimate Contour Mini
Indications for Use (Describe)
- Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. 2) Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.
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
510(k) Summarv
Applicant Information:
| Company Name: | CAO Group, Inc. |
|---|---|
| Company Address: | 4628 West Skyhawk Drive |
| West Jordan, Utah 84084 U.S.A. | |
| Company Phone: | 1-801-256-9282 |
| Company Fax: | 1-801-256-9287 |
| Contact Person: | Robert K. Larsen |
October 27, 2020
Preparation Date:
Device Name:
Trade Name: Ultimate Contour and Ultimate Contour Mini Common Name 1: Massager, vacuum, radio frequency induced heat PBX Product Code 1: 878.4400 Regulation 1: Product Classification 1: Class II Common Name 2: Focused ultrasound stimulator for aesthetic use Product Code 2: OHV Regulation 2: 878.4590 Product Classification 2: Class II
Legally Marketed Predicate Devices for Substantial Equivalence:
Ultimate Contour, manufactured by CAO Group, Inc. (K171052)
UltraShape, manufactured by Syneron Medical, Ltd. (K141708)
Description of Submitted Device:
The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.
Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.
4
K201475
The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.
Indications for Use of the Submitted Device:
The submitted device is indicated for -
-
- Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
-
- Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.
| Summary of Technological Characteristics and Substantial Equivalence: | |||
|---|---|---|---|
| CAO Group, Inc. | |||
| Ultimate Contour | CAO Group, Inc. | ||
| Ultimate Contour | |||
| K171052 | Syneron Medical, Ltd. | ||
| UltraShape | |||
| K141708 | |||
| Ultrasound | |||
| Frequency | 37kHz | Not Present | 200kHz |
| Ultrasound | |||
| Power | 1.00 W/cm² | Not Present | 17 W/cm² |
| Ultrasound | |||
| Focal Distance | 6mm | Not Present | 15mm |
| Electrical | |||
| Power Input | |||
| (System) | 100-240VAC, 50-60Hz, 207VA | 100-240VAC, 50-60Hz, | |
| 207VA | 110-120/200-240VAC, 50/60Hz | ||
| Cooling | |||
| Method | |||
| (Handpiece) | Heatsink/Air Convection | Heatsink/Air Convection | Not available |
| Cooling | |||
| Method (Unit) | Heatsink / Fan air cooled | Heatsink / Fan air cooled | Not available |
| Application | |||
| Time | 10-40 minutes | 10-40 minutes | 30-60 minutes |
| Dimensions | (Model 005-00035): 19" x 19" x | ||
| 50" | |||
| (Model 005-00036): 13.75" x | |||
| 14.5" x 14" | (Model 005-00035): 19" x | ||
| 19" x 50" | |||
| (Model 005-00036): 13.75" | |||
| x 14.5" x 14" | 25.6" x 38.6" x 78.75" | ||
| Weight | (Model 005-00035): 45.0 lbs. | ||
| (Model 005-00036): 5.0 lbs | (Model 005-00035): 45.0 lbs. | ||
| (Model 005-00036): 5.0 lbs | 285.0 lbs. |
5
| | CAO Group, Inc.
Ultimate Contour | CAO Group, Inc.
Ultimate Contour
K171052 | Syneron Medical, Ltd.
UltraShape
K141708 |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface | Interactive color LCD
touchscreen | Interactive color LCD
touchscreen | Interactive color LCD
touchscreen |
| Patient-
Contacting
Materials | Stainless Steel
Nylon Plastic | Stainless Steel
Nylon Plastic | Stainless Steel
ABS Plastic |
| Sterilization of
Patient-
Contacting
Materials | None Specified | None Specified | None Specified |
| Environment
of Use | Controlled medical office or
practice | Controlled medical office or
practice
K171052 | Controlled medical office or
practice
K141708 |
| 510(k)
Number | Pending this application | K171052 | K141708 |
| Indications for
Use | 1) Application of non-thermal
radio frequency for relief of
minor muscle aches and
pains, relief of muscle
spasm, temporary
improvement of local blood
circulation, and temporary
reduction in the appearance
of cellulite.
- Application of ultrasound for
non-invasive reduction in
abdominal circumference on
adults with a Body Mass
Index (BMI) of 25 or greater. | Application of non-thermal
radio frequency for relief of
minor muscle aches and
pains, relief of muscle
spasm, temporary
improvement of local blood
circulation, and temporary
reduction in the
appearance of cellulite. | The UltraShape System delivers
focused ultrasound energy that
can disrupt subcutaneous
adipose tissue (SAT) to provide
a non-invasive approach to
achieve a desired aesthetic
effect. It is intended for non-
invasive reduction in abdominal
circumference. |
Rationale for Substantial Equivalence:
The submitted device shares the same indications for use as the predicates. The submitted device utilizes the same energy type and means of energy application as the predicate devices. The submitted device is used by the same type of operator as the predicate devices. The submitted device provides for similar user interface and control mechanisms as the predicate devices. Ultrasound component of subject device has technological differences to compare to the predicate. Pre-clinical performance testing was performed to evaluate substantial equivalence of ultrasound component to the predicate.
Performance Data:
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY
The Ultimate Contour is demonstrated to comply with the performance requirements of IEC 60601-1: 3ª Edition, IEC 60601-1-2: 3rd Edition with gap analysis to 4th Edition, and IEC 60601-1-6.
PERFORMANCE BENCH TESTING
Bench testing per internal verification testing demonstrates that the Ultimate Contour meets the essential performance requirements established for the device, including measurements of the radio frequency power
6
generated, and essential aspects of hardware and software performance. The software of this device is stated as a Major level of concern since failure of the software could present significant risk to the patient. All essential functions are demonstrated to work according to design specifications.
BIOCOMPATIBILITY
Materials used in the patient-contacting portions of this device are equivalent to legally marketed reference devices listed above that incorporate patient-contacting articles used for contacting similar tissues.
CLINICAL PERFORMANCE TESTING
A clinical evaluation of the device on a representation of the intended population was performed in a single-site single-arm study. The study evaluated the safety and effectiveness of the device in waist circumference reduction. A total of 42 subjects completed the treatment regimen of the device with one week between each treatment, and 1-week follow ups. The safety analysis included all subjects who participated at any point during the course of the study. Effectiveness was gauged by determining if waist circumference reduction was achieved relative to a value identified as clinically meaningful, a value of at least 1 inch of waist circumference reduction of the treatment regimen. The clinically meaningful value was identified based on published studies utilizing other devices for the same purpose. Measurements were conducted prior to and after each treatment, and at the 1-week follow-up visits. Clinicians were blinded relative to measuring pre-treatment and post-treatment.
The study included subjects age 18 or older who met all inclusion criteria and none of the exclusion criteria. The majority of study subjects were Caucasian females. Mean age of the subjects was 42.8 years. Mean baseline waist circumference prior to the first treatment was measured at 40.95 inches, and an average initial BMI of 29.36. The primary effectiveness endpoint measured the difference between waist circumference prior to the first treatment with the device. The safety endpoint assessed all adverse events and serious adverse events occurring during the study.
The study results for the primary endpoint demonstrated an average circumference reduction of 2.0 inches to the 4-week follow up visit, which was statistically significant compared to the target threshold of 1.0 inches (p=0.05). The greatest circumference reduction for this period was measured at 3.75 inches, and the least circumference reduction was measured at 0.75 inches. T-test and Kolmogorov-Smirnov tests demonstrated that the data can be considered normally distributed. Correlation analysis comparing the baseline measurements and 4-week follow-up measurements returned a correlation score of 0.9901. With all missing data imputed with a least-favorable regimen outcome (0.75 inch reduction), the effect of device treatment on circumference reduction remained greater than the 1.0 inch reduction threshold. The treatment was administered without anesthetic. 7 subjects reported a sensation of ringing or buzzing in the ears, which was substantial enough to cause 2 of the subjects to discontinue participation. Follow-up audiology assessment with these subjects identified no substantial or worsening audible capabilities. Most adverse events resolved within 1-2 days after the treatment. These included skin rash, changes in bowel movement, and changes in urine consistency. The events were either self-resolved with the use of over-the-counter products.
Conclusion:
Comparison of subject and predicate devices identified technological similarities and differences. Performance testing was performed to evaluate substantial equivalence of dissimilar technological characteristics. Based on technological comparison to predicate devices and the results of pre-clinical performance testing, the Ultimate Contour device is substantially equivalent to the identified predicate devices.