(85 days)
Not Found
No
The description focuses on standard radiofrequency technology, a microprocessor-driven control unit, and user interface features. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "temporary relief of pain, muscle spasms, and increase in local circulation" and "a temporary reduction in the appearance of cellulite," which are all therapeutic benefits.
No
The device description and intended use state that it is for therapy (heating for pain relief, muscle spasms, circulation, and cellulite appearance reduction), not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a control unit, handpiece, massage heads, and a touch screen, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Exilis XP RF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing heating to elevate tissue temperature for medical conditions like pain relief, muscle spasms, and increased circulation, and for temporary reduction in the appearance of cellulite. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a radiofrequency device with massage heads for applying therapy. It focuses on the delivery of energy and massage, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Exilis XP device does not perform this function.
N/A
Intended Use / Indications for Use
The Exilis XP RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pains, and increase in local circulation. The Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
The Exilis XP is a state-of-the-art radiofrequency device, with integrated massaging heads, that enables the application of therapy by a non-invasive, high-frequency field.
The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip.
Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece display shows the selected treatment parameters.
The Exilis XP consists of the following main components:
- . microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- user interface with 8.4" color touch screen
- handpiece for an application of radiofrequency
- . two massage heads
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence determination for the Exilis XP system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilis XP and compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PelleFirm System (K132949)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
BTL Industries Incorporated Jan Zarsky Executive Vice President 47 Loring Drive Framingham, Massachusetts 01702
Re: K143040
Trade/Device Name: Exilis XP Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: December 29, 2014 Received: December 31, 2014
Dear Mr. Zarsky:
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
1
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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 below.
510(k) Number (if known)
Device Name Exilis XP
Indications for Use (Describe)
The Exilis XP RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pains, and increase in local circulation. The Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
| 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a logo with three blue squares connected in the center. Each square has a letter inside: 'B' in the left square, 'T' in the center square, and 'L' in the right square. The letters are also in blue and have a bold, sans-serif font. The squares are oriented diagonally, creating a visually interconnected design.
Section 5 – 510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | Jan Zarsky
BTL Industries, Inc.
Executive VP
zarsky@btlnet.com |
Summary Preparation 14 September 2014 Date:
Device Names
| Trade/Proprietary Name: | Exilis XP |
|---|---|
| Primary Classification Name: | Electrosurgical cutting and coagulation and |
| accessories | |
| Classification Regulation: | 878.4400 |
| Product Code: | PBX |
Legally Marketed Predicate Devices
The Exilis XP system is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number:
- PelleFirm System (K132949) .
Product Description
The Exilis XP is a state-of-the-art radiofrequency device, with integrated massaging heads, that enables the application of therapy by a non-invasive, high-frequency field.
4
Image /page/4/Picture/0 description: The image shows a blue logo with the letters BTL. The letters are inside of three diamond shapes that are connected to each other. The logo is simple and modern.
The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip.
Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece display shows the selected treatment parameters.
The Exilis XP consists of the following main components:
- . microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- user interface with 8.4" color touch screen
- handpiece for an application of radiofrequency
- . two massage heads
Indications for Use
The Exilis XP RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain. muscle spasms, and increase in local circulation. The Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing
The Exilis XP device has been thoroughly evaluated for electrical safety. The Exilis XP has been found to conform with applicable medical device safety standards. The system complies with the following standards:
ISO 14971 - Medical devices - Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes
Medical Electrical Equipment
ISO 60601-1 General requirements for safety ISO 60601-1-2 Electromagnetic compatibility-Requirements and Tests ISO 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories ISO 60601-1-6 Usability ISO 10993-1 Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization
5
Image /page/5/Picture/0 description: The image shows the logo for BTL Clinical Testing. The logo consists of three blue squares that are nested inside of each other. The text "Clinical testing" is written in bold black letters below the logo.
The substantial equivalence determination for the Exilis XP system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilis XP and compared to the predicate device.
Comparison with the Predicate Device
| Device Name | Exilis XP | PelleFirm |
|---|---|---|
| Manufacturer | BTL Industries, Inc. | Ellman International, Inc. |
| 510(k) Number | Current Submission | K132949 |
| Regulation | General & Plastic Surgery | |
| 21 CFR 878.4400 | ||
| Electrosurgical cutting and | ||
| coagulation and accessories | General & Plastic Surgery | |
| 21 CFR 878.4400 | ||
| Electrosurgical cutting and | ||
| coagulation and accessories | ||
| Product Code | PBX | PBX |
| Indications for | ||
| Use | The Exilis XP RF device | |
| is | ||
| intended to provide heating for the | ||
| purpose of elevating tissue | ||
| temperature for selected medical | ||
| conditions such as temporary | ||
| relief of pain, muscle spasms, and | ||
| increase in local circulation. The | ||
| Exilis XP massage device is | ||
| intended to provide a temporary | ||
| reduction in the appearance of | ||
| cellulite. | The PelleFirm RF device is | |
| intended to provide heating for the | ||
| purpose of elevating tissue | ||
| temperature for selected medical | ||
| conditions such as temporary relief | ||
| of pain, muscle spasms, and | ||
| increase in local circulation. The | ||
| PelleFirm massage device is | ||
| intended to provide a temporary | ||
| reduction in the appearance of | ||
| cellulite. | ||
| Device | ||
| Technologies | Application of the heat to the | |
| tissue via RF energy. Massaging | ||
| of body parts with massage | ||
| device. | Application of the heat to the | |
| tissue via RF energy. Massaging | ||
| of body parts with massage | ||
| device. | ||
| Electrical | ||
| Protection | Class II, BF | Class I, BF |
| Color Touch | ||
| Screen | 8.4" (21.5cm)/640x480 pixel | N/A |
| RF Tip | ||
| Diameter | 1.8cm | 2.3cm |
| Maximum | ||
| Output | ||
| Power | 120W | 120W |
| Device Name | Exilis XP | PelleFirm |
| Manufacturer | BTL Industries, Inc. | Ellman International, Inc. |
| 510(k) Number | Current Submission | K132949 |
| Effective | ||
| Treatment | ||
| Temperature | 40 - 45 °C | 40 - 45 °C |
| Modes of | ||
| Operation | Monopolar | Monopolar |
| Output | ||
| Frequency | 3.25MHz | 4 MHz |
| Massage | ||
| Attachment | ||
| Material | White Plastic material | White Plastic material |
| Massage | ||
| Attachment 1 | Diameter 80 mm, | |
| Massage ball diameter 19mm, | ||
| Massage ball number: 5 | Diameter 80 mm, | |
| Massage ball diameter 19, | ||
| Massage ball number: 5 | ||
| Massage | ||
| Attachment 2 | Diameter 52mm, | |
| Massage ball diameter 12mm | ||
| Massage ball number: 5 | Diameter 52mm, | |
| Massage ball diameter 12mm, | ||
| Massage ball number: 5 | ||
| Energy Source | 100 - 240 VAC, max 4A, 50-60 Hz | 110 - 240 V, max 4A, 50-60 Hz |
| Dimensions | ||
| (W x H x D) | 16" x 10.6" x 11.9" | |
| (41 cm x 22 cm x 18 cm) | 9.5" x 7.1" x 16.5" | |
| (24 cm x 18 cm x 42 cm) | ||
| Weight | 16 lb (7.3 kg) | 26 lb (11.8 kg) |
6
Image /page/6/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three interconnected squares. The squares are oriented diagonally, and the letters are in white.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the Exilis XP device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusion
Based on the aforementioned information, the Exilis XP is safe and effective and substantially equivalent to the identified predicate device.