(59 days)
The Exilis XP II 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 II massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Exilis XP II is a state-of-the-art radiofrequency device 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 quides 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. Exilis XP II comes with the opportunity of exchangeable tips for patients greater convenience when treating various body parts. 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 II consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator for an application of radiofrequency, exchangeable applicator tips to treat various body parts.
This document is a 510(k) premarket notification for the Exilis XP II device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Exilis XP) rather than providing detailed acceptance criteria and a study to prove meeting them in the context of typical AI/software device performance.
Therefore, many of the requested points related to acceptance criteria, sample size, ground truth, expert adjudication, and comparative effectiveness studies for AI will not be fully answerable based on the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way a performance study for an AI/software device would. Instead, the acceptance criteria are implicitly that the Exilis XP II performs as intended, safely, and in a similar manner to the predicate device. The "performance" is demonstrated through comparison of technical characteristics and compliance with safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Exilis XP II) |
|---|---|
| Intended Use Alignment | "The Exilis XP II 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 II massage device is intended to provide a temporary reduction in the appearance of cellulite." (Matches predicate device's indications) |
| Safety and Efficacy | "The Exilis XP II device has been thoroughly evaluated for electrical safety. The Exilis XP II has been found to conform with applicable medical device safety standards... Non-clinical test have been conducted to evaluate the Exilis SP II performance, and results confirm that the device performs as intended and in a similar manner compared to the predicate." "The changes in Exilis XP II do not raise any new questions of safety and effectivity." |
| Technical Equivalence | The comparison table (pages 5-6) shows identical technical specifications (Device Technologies, Electrical Protection, Color Touch Screen size, Maximum Output Power, Effective Treatment Temperature, Modes of Operation, Output Frequency, Energy Source, Dimensions, Weight) except for the addition of "Exchangeable Applicator Tips Available." |
| Compliance with Standards | ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-1, ISO 10993-5, ISO 10993-10. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document explicitly states: "The substantial equivalence determination for the Exilis XP II system is not based upon clinical performance testing." Therefore, there is no clinical test set, sample size, or data provenance information in the context of clinical performance data. The evaluation was primarily based on non-clinical (engineering, safety, and performance as compared to the predicate) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance test set was used for substantial equivalence. "Ground truth" in this context refers to compliance with engineering and safety standards, and technical specifications compared to the predicate, which would be assessed by engineers and regulatory experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Exilis XP II is a physical medical device (radiofrequency and massage device), not an AI/software device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is established through:
- Compliance with recognized electrical safety and medical device software standards (ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993 series for biological evaluation).
- Technical specifications that match or are equivalent to the predicate device.
- "As intended" performance demonstrated through non-clinical testing.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures in profile, representing health and human services. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2017
BTL Industries, Inc. Mr. David Chmel 47 Loring Drive Framingham, Massachusetts 01702
Re: K163176
Trade/Device Name: Exilis XP II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: December 19, 2016 Received: December 22, 2016
Dear Mr. Chmel:
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 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 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,
Jennifer R. Stevenson -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Exilis XP II
Indications for Use (Describe)
The Exilis XP II 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 II massage device is intended to provide a temporary reduction in the appearance of cellulite.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping blue squares, each containing the letters "BTL". To the right of the logo is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the text is clear and easy to read.
Tel: +1-866-285-1656
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702 |
| Fax: +1-888-499-250 | |
|---|---|
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
Summary Preparation 27 October 2016 Date:
Device Names
| Trade/Proprietary Name: | Exilis XP II |
|---|---|
| Primary Classification Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Regulation: | 878.4400 |
| Product Code: | PBX |
Legally Marketed Predicate Devices
The Exilis XP II 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:
- . Exilis XP (K143040)
Product Description
Subject of the submission is approval of design changes, improvement of the device ergonomics, hygiene and cleaning through addition of exchangeable and single use applicator tips.
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The Exilis XP II is a state-of-the-art radiofrequency device 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 quides 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.
Exilis XP II comes with the opportunity of exchangeable tips for patients greater convenience when treating various body parts.
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 II consists of the following main components:
- microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- . user interface with 8.4" color touch screen
- applicator for an application of radiofrequency .
- . exchangeable applicator tips to treat various body parts
Indications for Use
The Exilis XP II 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 II massage device is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing
The Exilis XP II device has been thoroughly evaluated for electrical safety. The Exilis XP II 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
IEC 60601-1 General requirements for safety IEC 60601-1-2 Electromagnetic compatibility-Requirements and Tests
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- IEC 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories
- Evaluation and testing within a risk management process ISO 10993-1
- 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
Clinical testing
The substantial equivalence determination for the Exilis XP II system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilis XP II and compared to the predicate device.
Summary of Clinical and Non-clinical testing
Non-clinical test have been conducted to evaluate the Exilis SP II performance, and results confirm that the device performs as intended and in a similar manner compared to the predicate. Thus, the Exilis XP II is substantially equivalent to the predicate devices.
| Device Name | Exilis XP II | Exilis XP |
|---|---|---|
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number | Current Submission | K143040 |
| Product Code | General & Plastic Surgery21 CFR 878.4400 | General & Plastic Surgery21 CFR 878.4400 |
| Regulation | • PBX, Electrosurgical, Cutting &Coagulation & Accessories | • PBX, Massager, Vacuum, RadioFrequency Induced Heat |
| Indications forUse | The Exilis XP II RF device isintended to provide heating for thepurpose of elevating tissuetemperature for selected medicalconditions such as temporaryrelief of pain, muscle spasms, andincrease in local circulation. TheExilis XP II massage device isintended to provide a temporaryreduction in the appearance ofcellulite. | The Exilis XP RF device isintended to provide heating for thepurpose of elevating tissuetemperature for selected medicalconditions such as temporary reliefof pain, muscle spasms, andincrease in local circulation. TheExilis XP massage device isintended to provide a temporaryreduction in the appearance ofcellulite. |
Comparison with the Predicate Device
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| Device Name | Exilis XP II | Exilis XP |
|---|---|---|
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number | Current Submission | K143040 |
| DeviceTechnologies | Application of the heat to thetissue via RF energy. Massagingof bodyparts withmassagedevice. | Application of the heat to thetissue via RF energy. Massagingof bodyparts withmassagedevice. |
| ElectricalProtection | Class II, BF | Class II, BF |
| Color TouchScreen | 8.4" (21.5cm)/640x480 pixel | 8.4" (21.5cm)/640x480 pixel |
| ExchangeableApplicatorTips Available | Yes | No |
| MaximumOutputPower | 120 W | 120 W |
| EffectiveTreatmentTemperature | 40 - 45 °C | 40 - 45 °C |
| Modes ofOperation | Monopolar | Monopolar |
| OutputFrequency | 3.25 MHz | 3.25 MHz |
| Energy Source | 100 - 240 VAC, max 4A, 50-60 Hz | 100 - 240 VAC, 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) | 16" x 10.6" x 11.9"(41 cm x 22 cm x 18 cm) |
| Weight | 16 lb (7.3 kg) | 16 lb (7.3 kg) |
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the Exilis XP II device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusion
Based on the aforementioned information, the changes in Exilis XP II do not raise any new questions of safety and effectivity and the device is substantially equivalent to the identified predicate device.
§ 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.