(181 days)
The XP3000 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 XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The XP3000 is a state-of-the-art radiofrequency device with massage attachments 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 handpieces are 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 displays show the selected treatment parameters. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data. The XP3000 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, handpiece XP (215/3), two massage attachments for the XP handpiece, large handpiece (215/1) with integrated massage part, large handpiece (215/1).
The provided document is a 510(k) premarket notification for the XP3000 device. It states that the device is substantially equivalent to a predicate device (Exilis XP, K143040) and includes information about non-clinical testing and a clinical performance test.
However, the document does NOT contain the specific details requested regarding acceptance criteria, reported device performance measurements, sample sizes, data provenance, expert qualifications, or adjudication methods for the clinical study.
The clinical testing section only states: "The substantial equivalence determination for the XP3000 is based on clinical performance testing. The aim of the performance test was to prove that XP3000 device reaches the effective treatment temperature and maintain it for required time." It then provides a table comparing the XP3000 to the predicate device, but this table lists device specifications (like temperature range, power, dimensions) rather than specific performance metrics from a study that would demonstrate meeting acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a study, nor can I provide answers to most of the specific questions about the study design that would prove the device meets acceptance criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Indirect/Implied): The document implies an acceptance criterion for the clinical performance test: that the XP3000 device "reaches the effective treatment temperature and maintain it for required time." The "Effective Treatment Temperature" is listed as 40 - 45 °C in the comparison table for both the XP3000 and the predicate device.
- Reported Device Performance: The document states that the substantial equivalence is based on clinical performance testing, but it does not report the specific results from that testing (e.g., "95% of treatments achieved 40-45°C for X minutes," or specific data points). It only lists the target effective treatment temperature.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not specify the sample size or data provenance for the clinical performance test.
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/provided. The clinical performance test was focused on reaching and maintaining temperature, not on interpretations requiring expert ground truth (like image analysis for cellulite reduction efficacy where experts might be needed to rate appearance changes). No information on experts is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/provided. Given the focus on temperature reaching and maintenance, a typical adjudication method for interpretation would not be relevant. The document provides no information on any such method.
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
- No. This type of study (MRMC for human readers with/without AI assistance) is not mentioned and is not relevant to the described clinical performance test for a radiofrequency device that aims to elevate tissue temperature.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/provided. The device is a physical RF device. The mention of "Software Life Cycle Processes" (IEC 62304) suggests software is involved in control, but a standalone algorithm performance without human-in-the-loop is not described for a diagnostic or interpretative task. The "clinical performance testing" refers to the device's ability to achieve a physical effect.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth (Implied): The "ground truth" for the clinical performance test was likely the actual tissue temperature measured during the treatment, compared against the target effective treatment temperature of 40-45°C. The document does not explicitly state the measurement method or its validation.
8. The sample size for the training set
- Not applicable/provided. The document does not describe AI/ML components requiring a training set in the conventional sense for diagnostic or predictive tasks. The software mentioned (IEC 62304) is for device control, not for learning from a dataset to perform a task.
9. How the ground truth for the training set was established
- Not applicable/provided. See point 8.
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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 stylized caduceus with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
BTL Industries Incorporated Ms. Jan Zarsky Executive Vice President 47 Loring Drive Framingham, Massachusetts 01702
Re: K150720
Trade/Device Name: XP3000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: August 18, 2015 Received: August 20, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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.
Sincerelv vours.
Joshua C. Nipper -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150720
Device Name XP3000
Indications for Use (Describe)
The XP3000 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 XP3000 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)
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Image /page/3/Picture/0 description: The image shows a logo for an organization with the letters BTL in it. The letters are inside of three diamond shapes that are connected to each other. The logo is blue.
Section 5 - 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 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | Jan ZarskyBTL Industries, Inc.Executive VP |
Summary Preparation 12 February 2015 Date:
Device Names
| Trade/Proprietary Name: | XP3000 |
|---|---|
| Primary Classification Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Regulation: | 878.4400 |
| Product Code: | PBX |
Legally Marketed Predicate Devices
The XP3000 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
The XP3000 is a state-of-the-art radiofrequency device with massage attachments 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
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Image /page/4/Picture/0 description: The image shows a logo with the letters B, T, and V. The letters are arranged in a row, with each letter enclosed in a diamond shape. The diamonds are connected to each other, forming a chain-like pattern. The logo is blue in color and has a modern, geometric design.
easier control, the handpieces are 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 displays show the selected treatment parameters.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.
The XP3000 consists of the following main components:
- microprocessor-driven control unit .
- . high-frequency electromagnetic energy generator
- . user interface with 8.4" color touch screen
- . handpiece XP (215/3)
- . two massage attachments for the XP handpiece
- . large handpiece (215/1) with integrated massage part
- . large handpiece (215/1)
Indications for Use
The XP3000 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 XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing
The XP3000 device has been thoroughly evaluated for electrical safety. The XP3000 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
- Evaluation and testing within a risk management process ISO 10993-1
- ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity
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Image /page/5/Picture/0 description: The image shows a logo with three interconnected squares in blue. Inside the squares are the letters 'B', 'T', and 'L', respectively. Below the logo, the text 'ISO 1099' is displayed, indicating a reference to the ISO 1099 standard.
ISO 10993-10 Biological Evaluation of Medical Devices—Test for Irritation and Skin Sensitization
Clinical testing
The substantial equivalence determination for the XP3000 is based on clinical performance testing. The aim of the performance test was to prove that XP3000 device reaches the effective treatment temperature and maintain it for required time.
| Comparison with the Predicate Device | |
|---|---|
| -------------------------------------- | -- |
| Device Name | XP3000 | 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, Massager, Vacuum, RadioFrequency Induced Heat | · PBX, Massager, Vacuum, RadioFrequency Induced Heat |
| Indications forUse | The XP3000 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. TheXP3000 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. |
| DeviceTechnologies | Application of the heat to thetissue via RF energy. Massagingof body parts with massageattachment. | Application of the heat to thetissue via RF energy. Massagingof body parts with massageattachment. |
| ElectricalProtection | Class II, BF | Class II, BF |
| Color TouchScreen | 8.4" (215mm)/640×480 pixel | 8.4" (215mm)/640×480 pixel |
| RF TipDiameter XPHandpiece(215/3) | 18mm | 18mm |
| RF TipDiameterLarge | 21.4mm | N/A |
| Device Name | XP3000 | Exilis XP |
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number | Current Submission | K143040 |
| Handpiece | ||
| with Integrated | ||
| Massage Part | ||
| (215/1) | ||
| RF Tip | 21.4mm | N/A |
| Diameter | ||
| LargeHandpiece | ||
| without | ||
| Integrated | ||
| Massage Part | ||
| (215/1) | ||
| Maximum | Handpiece 215/3 - 120W | Handpiece 215/3 - 120W |
| Output | Handpiece 215/1 - 170W | Handpiece 215/1 - N/A |
| Power | ||
| Energy | 0.473 W/mm² | 0.472 W/mm² |
| Density | ||
| Effective | 40 - 45 °C | 40 - 45 °C |
| Treatment | ||
| Temperature | ||
| Large | YES | N/A |
| Handpiece | ||
| (215/1) Cooling | ||
| Modes of | Monopolar | Monopolar |
| Operation | ||
| Output | 3.25MHz ± 50kHz | 3.25MHz ± 50kHz |
| Frequency | ||
| Massage | Grey Plastic material | Grey Plastic material |
| Attachment | ||
| Material | ||
| Massage | Diameter 80 mm, | Diameter 80 mm, |
| Attachment 1 | Massage ball diameter 19mm, | Massage ball diameter 19mm, |
| (XP | Massage ball number: 5 | Massage ball number: 5 |
| Handpiece)Massage | Diameter 52mm, | Diameter 52mm, |
| Attachment 2 | Massage ball diameter 12mm | Massage ball diameter 12mm |
| (XP | Massage ball number: 5 | Massage ball number: 5 |
| Handpiece) | ||
| Massage Part | Diameter 80mm, | N/A |
| (Large | Massage ball diameter 19mm, | |
| Handpiece) | Massage ball number: 5 | |
| Device Name | XP3000 | Exilis XP |
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number Current Submission | K143040 | |
| Energy Source 100 - 240 VAC, max 4A, 50-60 Hz 110 - 240 V, max 4A, 50-60 Hz | ||
| Dimensions(W x H x D) | 600 × 1000 × 600mm(24" × 39" × 24") | 406 × 270 × 302mm(15.98" × 10.63" × 11.87") |
| Weight | 66 lb (30 kg) | 16 lb (7.3 kg) |
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Image /page/6/Picture/0 description: The image shows a blue logo with the letters B, T, and L. Each letter is inside of a diamond shape. The diamonds are connected to each other, creating a chain-like effect. The logo is simple and modern.
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Image /page/7/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in a stylized font and are arranged in a row. Each letter is enclosed in a diamond shape. The logo is blue and the background is white.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the XP3000 device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusion
Based on the aforementioned information, the XP3000 is safe and effective and 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.