(177 days)
No
The description mentions a "microprocessor-driven control unit" and "software for control of the entire equipment," but there is no mention of AI, ML, or related concepts like image processing, deep learning, or training/test sets for algorithmic performance. The performance study focuses on clinical outcomes, not algorithmic validation.
Yes
The device is indicated for "temporary reduction in circumference of the abdomen" and performs a physical change (disruption of adipocyte cells) to achieve this outcome, aligning with the definition of a therapeutic device.
No
The device is described as an RF system for temporary reduction in circumference of the abdomen, indicating a therapeutic or cosmetic purpose rather than a diagnostic one.
No
The device description clearly outlines multiple hardware components including a multi-jointed arm, applicator, control unit with electronic system for electromagnetic field generation, touch screen, and a cart. While it mentions software within the control system, it is an integral part of a larger hardware system.
Based on the provided information, the XP1000 RF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary reduction in circumference of the abdomen." This is a therapeutic or aesthetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that generates a high-frequency electromagnetic field and applies it externally to the body. This is consistent with a physical therapy or aesthetic device, not an IVD which would involve analyzing biological samples.
- Performance Studies: The performance studies focus on measuring changes in abdominal circumference and the absence of adverse events. These are outcomes related to a physical treatment, not the accuracy or reliability of a diagnostic test.
In summary, the XP1000 RF device is designed to physically alter the body (reduce circumference) rather than to diagnose or provide information about a medical condition by examining biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen (waist)
Indicated Patient Age Range
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary efficacy outcome: >=3 cm waist circumferential reduction in more than 80% of subjects.
Mean circumferential reduction: >=1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point.
Secondary objective: no adverse events recorded.
Predicate Device(s)
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 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
1
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
2
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) |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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
"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 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 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: 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)
4
Image /page/4/Picture/0 description: The image shows a logo with the letters BTL in a stylized font. The letters are arranged within three interconnected diamond shapes. The logo is a solid blue color and is set against a white background.
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 Code | ||
| Regulation | General & Plastic | |
| Surgery | ||
| 21 CFR 878.4400 | ||
| -GEI, Electrosurgical | ||
| Cutting and | ||
| Coagulation | ||
| Device & | General & Plastic | |
| Surgery | ||
| 21 CFR 878.4400 | ||
| -GEI, Electrosurgical | ||
| Cutting and | ||
| Coagulation | ||
| Device & | ||
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical |
| Ltd. | ||
| Accessories. | Accessories. | |
| Indications for | ||
| Use | The XP1000 RF is | |
| indicated for | ||
| temporary reduction | ||
| in circumference of | ||
| the abdomen. | The Transcend is | |
| indicated for | ||
| temporary reduction | ||
| in circumference of | ||
| the abdomen. | ||
| Deep tissue | ||
| Heating | ||
| Electromagnetic | ||
| Energy | Radiofrequency | Radiofrequency + |
| InfraRed | ||
| Vacuum | No | Yes |
| Electrical | ||
| Protection | Class II, BF | Class I, BF |
| Unit | ||
| Construction | Constructed of | |
| materials that | ||
| conform with safety | ||
| standards and | ||
| requirements. | Constructed of | |
| materials that | ||
| conform with safety | ||
| standards and | ||
| requirements. | ||
| Interface | Touch-screen user | |
| applied interface to | ||
| program and set the | ||
| controls for the | ||
| patient application; | ||
| there is an applicator | ||
| utilized to deliver the | ||
| treatment. | Touch-screen user | |
| applied interface to | ||
| program and set the | ||
| controls for the | ||
| patient application; | ||
| there is a hand- | ||
| piece utilized to | ||
| deliver the | ||
| treatment. | ||
| Color Touch | ||
| Screen | 8.4" | |
| (21.5cm)/640x480 | ||
| pixel | 10.1" (25.7 cm) | |
| Modes Of | ||
| Operation | Bipolar | Bipolar |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron |
| Medical | ||
| Ltd. | ||
| Nominal | ||
| Operating | ||
| Power | Max: 200W RF | Max: 151.7W (150W |
| RF, 1.7 or 3.3W IR) | ||
| RF Carrier | ||
| Frequency | 27.12 | |
| (±400kHz) MHz | 1 MHz | |
| Operating | ||
| Temperature | 10°C to 30°C | 15°C to 30°C |
| Operating | ||
| Humidity | 30% - 75% | Up to 80% |
| Skin | ||
| Temperature | ||
| Monitoring | Based on patient's | |
| feedback. External | ||
| IR thermometer. | Based on patient's | |
| feedback. Built-in IR | ||
| thermometer. | ||
| Treatment | ||
| Temperature | ||
| Range | 40°C - 45°C | 40°C - 45°C |
| Cooling | Not Available | Not Available |
| Cooling | ||
| Mechanism | Not Available | Not Available |
| Applicator | ||
| Holder | YES | YES |
| Availability | ||
| Waveform | Sinusoid | Sinusoid |
| Applicator | ||
| Effective | ||
| Area | 20,106 mm² | 1,250 mm² |
| 750 mm² | ||
| 130 mm² | ||
| Treatment Time | Up to 45 min. per | |
| treated area (waist) | Up to 45 min. per | |
| treated area (waist) | ||
| Total Energy | ||
| Density | ||
| (fluence) | 3.6 - 27 J/mm² | 3.6 J/mm² |
| 6.0 J/mm² | ||
| 34.6 J/mm² | ||
| Material of the | ||
| Generator Case | Plastic/metal | Plastic/metal |
| Dual Dispersive | ||
| Patch Electrode | ||
| Grounding | NO | NO |
| Patch Electrode | ||
| Contact Quality | ||
| Monitoring | 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.