(177 days)
The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.
The XP1000 RF is indicated for temporary reduction in circumference of the abdomen.
The XP1000 RF system is designed for temporary reduction in circumference of the abdomen by means of high-frequency electromagnetic field. The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and unlock the joints to make positioning the applicators to the patient quick, easy and secure. The control unit consists of the control system and the electronic system. The control system contains the main microcomputer and software for control of the entire equipment; the electronic system contains the complete electromagnetic field generation. Easy-to-use color touch screen allows for maximum operator comfort. A large control knob is provided to increase and decrease output power. The XP1000 RF system is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The XP1000 RF consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator on a multi-jointed arm.
The document describes the XP1000 RF device, which is an electrosurgical cutting and coagulation device and accessories indicated for the temporary reduction of abdominal circumference.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Primary Efficacy Outcome Measure) | Reported Device Performance (XP1000 RF Treatment Group) |
|---|---|
| ≥3 cm waist circumferential reduction in more than 80% of subjects. | Achieved ≥3 cm waist circumferential reduction in more than 80% of subjects. |
| Mean circumferential reduction of XP1000 RF Treatment Group ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point. | The mean circumferential reduction was ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point. |
| Acceptance Criteria (Secondary Objective - Safety) | Reported Device Performance |
| Absence of adverse events (AE) associated with the treatment procedure. | No adverse events were recorded. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 60 subjects (40 in the XP1000 RF Treatment Group and 20 in the Sham/Placebo Group). All but one subject completed the study.
- Data Provenance: The document does not specify the country of origin of the data. The study was a "double-blinded study," indicating it was a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for assessing the waist circumference measurements. However, in clinical trials involving objective measurements like waist circumference, the "ground truth" is typically established by trained clinical staff following a standardized measurement protocol rather than a panel of experts. The data appears to be quantitative measurements.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method like 2+1 or 3+1. Given that the primary outcome is a quantitative measurement (waist circumference reduction) and it was a double-blinded study, it's highly probable that measurements were taken by trained personnel, and statistical analysis was used to compare the groups. Adjudication methods are more commonly used for subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial comparing a treatment group to a placebo group in terms of an objective physical measurement (waist circumference reduction).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable to the XP1000 RF device. The device is a physical medical device (electrosurgical cutting and coagulation device) that performs a physical intervention on a patient, not an AI algorithm. The study assesses the device's clinical efficacy in reducing abdominal circumference in human subjects.
7. The Type of Ground Truth Used:
The ground truth used was objective quantitative measurements of waist circumference. These measurements were taken at baseline and at 30-day and 90-day follow-up evaluations.
8. The Sample Size for the Training Set:
This question is not applicable. The XP1000 RF is a physical medical device, not an AI algorithm that requires a training set in the typical sense of machine learning. The clinical study described is for validating the device's effectiveness and safety, not for training a model.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with a design above them that resembles a bird or abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
BTL Industries Incorporated % Dr. Michail Pankratov MMP Medical Associates, LLC 16 Appleton Street Waltham, Massachusetts 02453
Re: K143559
Trade/Device Name: XP1000 RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 6, 2015 Received: May 7, 2015
Dear Dr. Pankratov:
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.
Sincerely yours.
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
F
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 XP1000 RF
Indications for Use (Describe)
The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.
| 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 BTL, which is a telecommunications company in Belize. The logo consists of three interconnected blue diamonds. The letters "B", "T", and "L" are placed inside the diamonds, with each letter in a separate diamond.
K143559 Page 1 of 6
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 Drive |
Framingham, MA 01702 Tel: +1-866-285-1656 Fax: +1-888-499-2502
- Contact Person: Michail Pankratov MMP Medical Associates, LLC 16 Appleton Street Waltham, MA 02453 Tel: +1-617-480-4543 Fax: +1 781 207 4676
| Summary Preparation | |
|---|---|
| Date: | June 3, 2015 |
Device Names
| Trade/Proprietary Name: | XP1000 RF |
|---|---|
| Primary Classification Name: | Electrosurgical Cutting and Coagulation Device & Accessories |
| Classification Regulation: | 878.4400 |
| Product Code: | GEI |
Legally Marketed Predicate Devices
The XP1000 RF system is a state-of-the-art high-frequency energy device with accessory, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number:
- Transcend System (K120510)
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Product Description
The XP1000 RF system is designed for temporary reduction in circumference of the abdomen by means of high-frequency electromagnetic field.
The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and unlock the joints to make positioning the applicators to the patient quick, easy and secure.
The control unit consists of the control system and the electronic system. The control system contains the main microcomputer and software for control of the entire equipment; the electronic system contains the complete electromagnetic field generation. Easy-to-use color touch screen allows for maximum operator comfort. A large control knob is provided to increase and decrease output power.
The XP1000 RF system is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office.
The XP1000 RF consists of the following main components:
- . microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- . user interface with 8.4" color touch screen
- . applicator on a multi-jointed arm
Indications for Use
The XP1000 RF is indicated for temporary reduction in circumference of the abdomen.
Non-clinical Testing
The XP1000 RF device has been thoroughly evaluated for electrical safety and performance. The XP1000 RF 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 IEC 60601-1-6 Usability IEC 60601-2-2 Particular requirements for basic safety and performance of high frequency surqical equipment ISO 10993-1 Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity
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Image /page/5/Picture/1 description: The image shows a logo with three blue diamond shapes interlocked. The letters "BTL" are arranged inside the diamond shapes. The logo is simple and modern, with a clean design.
ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization
Clinical testing
The device was clinically tested for reduction of abdominal circumference by disruption of adipocvte cells.
Sixty subjects, ranging from 19 to 53 years of age, were enrolled in the double blinded study and divided into 2 groups: 40 to the XP1000 RF Treatment Group and 20 to the Sham (Placebo) Group. All subiects but one finished the study.
The Treatment Group subjects have met the primary efficacy outcome measure by achieving ≥3 cm waist circumferential reduction in more than 80% of subjects. The mean circumferential reduction was ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point.
Waist circumference changes (Baseline data vs the 30-day and 90-day Follow Up data) between the XP1000 RF Treatment subjects and the Placebo Group were statistically highly significant.
The secondary objective was absence of adverse events (AE) associated with the treatment procedure. The secondary objective was met with no adverse events recorded.
The clinical study supports the effectiveness of the device for temporary reduction of abdominal circumference.
The efficacy of XP1000 RF was not established at power level settings below maximum power of 200 points. The device is indicated for patients 22 years or older because its safety and effectiveness have not been established in pediatric patients younger than 22 years.
| 510(k) number | K143559 | K120510 |
|---|---|---|
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical Ltd. |
| Product CodeRegulation | General & PlasticSurgery21 CFR 878.4400-GEI, ElectrosurgicalCutting andCoagulationDevice & | General & PlasticSurgery21 CFR 878.4400-GEI, ElectrosurgicalCutting andCoagulationDevice & |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron MedicalLtd. |
| Accessories. | Accessories. | |
| Indications forUse | The XP1000 RF isindicated fortemporary reductionin circumference ofthe abdomen. | The Transcend isindicated fortemporary reductionin circumference ofthe abdomen. |
| Deep tissueHeatingElectromagneticEnergy | Radiofrequency | Radiofrequency +InfraRed |
| Vacuum | No | Yes |
| ElectricalProtection | Class II, BF | Class I, BF |
| UnitConstruction | Constructed ofmaterials thatconform with safetystandards andrequirements. | Constructed ofmaterials thatconform with safetystandards andrequirements. |
| Interface | Touch-screen userapplied interface toprogram and set thecontrols for thepatient application;there is an applicatorutilized to deliver thetreatment. | Touch-screen userapplied interface toprogram and set thecontrols for thepatient application;there is a hand-piece utilized todeliver thetreatment. |
| Color TouchScreen | 8.4"(21.5cm)/640x480pixel | 10.1" (25.7 cm) |
| Modes OfOperation | Bipolar | Bipolar |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | SyneronMedicalLtd. |
| NominalOperatingPower | Max: 200W RF | Max: 151.7W (150WRF, 1.7 or 3.3W IR) |
| RF CarrierFrequency | 27.12(±400kHz) MHz | 1 MHz |
| OperatingTemperature | 10°C to 30°C | 15°C to 30°C |
| OperatingHumidity | 30% - 75% | Up to 80% |
| SkinTemperatureMonitoring | Based on patient'sfeedback. ExternalIR thermometer. | Based on patient'sfeedback. Built-in IRthermometer. |
| TreatmentTemperatureRange | 40°C - 45°C | 40°C - 45°C |
| Cooling | Not Available | Not Available |
| CoolingMechanism | Not Available | Not Available |
| ApplicatorHolder | YES | YES |
| AvailabilityWaveform | Sinusoid | Sinusoid |
| ApplicatorEffectiveArea | 20,106 mm² | 1,250 mm²750 mm²130 mm² |
| Treatment Time | Up to 45 min. pertreated area (waist) | Up to 45 min. pertreated area (waist) |
| Total EnergyDensity(fluence) | 3.6 - 27 J/mm² | 3.6 J/mm²6.0 J/mm²34.6 J/mm² |
| Material of theGenerator Case | Plastic/metal | Plastic/metal |
| Dual DispersivePatch ElectrodeGrounding | NO | NO |
| Patch ElectrodeContact QualityMonitoring | YES | N/A |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical Ltd. |
| RF Energy Emission Indicator | YES; Information displayed on the screen of the unit | YES |
| Applicator Weight | 3.9 lbs (1760 g) | 2.2 lbs (1 kg) |
| Energy Source | 100 – 240 VAC, max 5A, 50 – 60Hz | 110 – 230 VAC, max 5A, 50Hz |
| External Exchangeable Fuse | 2 × T4A / 250V, tube fuse 5 × 20 mm | Available |
| System Dimensions | 22" × 39" × 22"(56 cm x 98 cm x 56 cm) | 15" × 19" × 51.8"(132 cm × 49 cm × 38 cm) |
| System Weight | 83 lbs (38 kg) | 44.1 lbs (20 kg) |
Comparison with the Predicate Device
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Image /page/6/Picture/1 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three diamond shapes that are linked together. The letter B is in the left diamond, the letter T is in the center diamond, and the letter L is in the right diamond. The logo is simple and modern.
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Image /page/7/Picture/1 description: The image shows a logo with the letters B, T, and L. The letters are in a sans-serif font and are arranged horizontally. Each letter is enclosed in a diamond shape. The logo is blue and is set against a white background.
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Image /page/8/Picture/1 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.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the XP1000 RF device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusion
Based on the aforementioned information, the XP1000 RF 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.