(193 days)
No
The description focuses on radio-frequency technology and control circuitry based on user selection, with no mention of AI or ML algorithms for decision-making, data analysis, or adaptive control.
Yes
The device is intended for the 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, which are all therapeutic claims.
No
The device description and intended use indicate it is a body sculpting device for therapeutic purposes (pain relief, muscle spasm relief, blood circulation improvement, cellulite reduction), not for diagnosing medical conditions.
No
The device description clearly details hardware components including a power source, control circuitry, applicator handpiece, delivery cable, and a physical enclosure, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for therapeutic purposes (relief of muscle aches, spasm, improved blood circulation, cellulite reduction) applied directly to the body. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The description details a device that delivers radio frequency energy to the body for heating tissue. This is a physical intervention, not a diagnostic test performed on a sample.
- Anatomical Site: The device is applied to specific anatomical sites on the body (abdomen, thigh, arm, neck, and face). IVDs work with biological samples, not directly on the body.
- Performance Studies: The performance study describes heating skin tissues on human patients, which aligns with a therapeutic device, not an IVD.
In summary, the Ultimate Contour is a therapeutic device that uses radio frequency energy applied to the body for various physical effects, not a device used to diagnose conditions by examining samples outside 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.
Product codes
PBX
Device Description
The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency 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 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.
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
abdomen, thigh, arm, neck, and face (for clinical testing)
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Clinical performance testing for radio frequency performance was conducted via a single-site study on 5 human patients with varying skin pigmentation and demonstrates that the device is capable of heating skin tissues of the abdomen, thigh, arm, neck, and face to 40-45°C within 10 minutes without exceeding 45°C, in support of the claimed indication for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 20, 2017
CAO Group, Inc. Mr. Robert Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084
Re: K171052
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 Dated: September 14, 2017 Received: September 18, 2017
Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 (DICE) 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 (DICE) 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, Jennifer R. Stevenson -S3
For 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
Indications for Use
510(k) Number (if known) K171052
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.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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 |
Robert K. Larsen Contact Person: Preparation Date: October 17, 2017
Device Name:
| Trade Name: | Ultimate Contour |
|---|---|
| Common Name: | Massager, vacuum, radio frequency induced heat |
| Product Code: | PBX |
| Regulation: | 878.4400 |
| Product Classification: | Class II |
Legally Marketed Predicate Devices for Substantial Equivalence:
Venus Legacy, manufactured by Venus Concept, Ltd. (K143554)
Legally Marketed Reference Devices:
Axiem Touch-N-Go Registration Pointer, manufactured by Medtronic Navigation, Inc. (K141833)
Bi-Funnel Gastrostomy Feeding Tube with ENFit Connector, manufactured by Xeridiem Medical Devices (K171347)
Description of Submitted Device:
The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency 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 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.
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
4
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.
| Summary of Technological Characteristics and Substantial Equivalence: | ||||
|---|---|---|---|---|
| CAO Group, Inc. | Venus Concept, Ltd. | |||
| Ultimate Contour | Venus Legacy | |||
| Radio Frequency | 1MHz | 1MHz | ||
| Radio Power | 80W | 150W | ||
| (Max.) | ||||
| Electrical Power | 100-240VAC, 50-60Hz, 207VA | 100/110/240VAC, 50/60Hz, 670VA | ||
| Input (System) | ||||
| Cooling Method | Heatsink/Air Convection | Not available | ||
| (Handpiece) | ||||
| Cooling Method | Heatsink / Fan air cooled | Not available | ||
| (Unit) | ||||
| Application Time | 10-40 minutes | 30 minutes | ||
| Dimensions | (Model 005-00035): 19" x 19" x 50" | 15.75″ x 15.75″ x 40″ | ||
| (Model 005-00036): 13.75" x 14.5" x 14" | ||||
| Weight | (Model 005-00035): 45.0 lbs. | 88.0 lbs. | ||
| (Model 005-00036): 5.0 lbs | ||||
| User Interface | Interactive color LCD touchscreen | Interactive color LCD touchscreen | ||
| Patient- | Stainless Steel | Stainless Steel | ||
| Contacting | Nylon Plastic | ABS Plastic | ||
| Materials | ||||
| Sterilization of | None Specified | None Specified | ||
| Patient- | ||||
| Contacting | ||||
| Materials | ||||
| Environment of | Controlled medical office or practice | Controlled medical office or practice | ||
| Use | ||||
| 510(k) Number | K171052 | K143554 | ||
| Indications for | Application of non-thermal radio frequency | The Venus Legacy CX device is intended for the | ||
| Use | for relief of minor muscle aches and pains, | treatment of the following medical conditions; | ||
| relief of muscle spasm, temporary | using LB2 and LF2 applicators for the delivery | |||
| improvement of local blood circulation, and | of non-thermal RF combined with massage and | |||
| temporary reduction in the appearance of | magnetic field pulses: | |||
| cellulite. | ● | |||
| Relief of minor muscle aches and pain, | ||||
| relief of muscle spasm | ||||
| Temporary improvement of local blood | ||||
| ● |
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5
| CAO Group, Inc.
Ultimate Contour | Venus Concept, Ltd.
Venus Legacy |
|-------------------------------------|------------------------------------------------------------------------|
| | circulation
• Temporary reduction in the appearance of
cellulite |
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 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.
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: 3" 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 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
Clinical performance testing for radio frequency performance was conducted via a single-site study on 5 human patients with varying skin pigmentation and demonstrates that the device is capable of heating skin tissues of the abdomen, thigh, arm, neck, and face to 40-45°C within 10 minutes without exceeding 45°C, in support of the claimed indication for this device.
Conclusion:
The Ultimate Contour is substantially equivalent to the listed predicate. This device shares identical intended use, identical operating principles, similar design features, and similar functional and performance characteristics.