(302 days)
Not Found
No
The summary describes a microprocessor-driven control unit and software for controlling the device, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on clinical outcomes and statistical analysis, not on the performance of an AI/ML algorithm.
Yes
The device is indicated for "temporary reduction in circumference of the abdomen and thighs," which is a therapeutic purpose. The performance studies also refer to "therapy" and "treatment".
No
The device description and intended use state that the device is for "temporary reduction in circumference of the abdomen and thighs" and "disruption of adipocyte cells," which are therapeutic rather than diagnostic functions.
No
The device description clearly outlines multiple hardware components including a control unit, electromagnetic energy generator, user interface with touch screen, applicator, and a cart. While it mentions software within the control unit, the device is fundamentally a hardware system that utilizes software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary reduction in circumference of the abdomen and thighs." This is a therapeutic or aesthetic purpose, not a diagnostic one.
- Device Description: The device description details a system that uses high-frequency electromagnetic fields applied externally to the body. This is consistent with a physical therapy or aesthetic device, not a device that analyzes samples from the body (which is the core of an IVD).
- Performance Studies: The performance studies focus on measuring changes in circumference and subject satisfaction, which are outcomes related to the physical effect of the device on the body, not the analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
The XP1100 RF is indicated for temporary reduction in circumference of the abdomen and thighs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The XP1100 RF system is designed for temporary reduction in circumference of the abdomen and thighs 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 XP1100 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 XP1100 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 and thighs
Indicated Patient Age Range
ranging from 23 to 54 years of age
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 XP1100 RF device was clinically tested for reduction of thighs circumference by disruption of adipocyte cells. Forty subjects (28 women, 12 men), ranging from 23 to 54 years of age, skin type in range from II to IV, race/ethnicity white, were enrolled in the open label study. Treated subjects received 4 treatment sessions (30 minutes per each leg) delivered once a week over a 4-week period.
The subjects have met the primary efficacy outcome measure by achieving ≥1 cm thighs circumferential reduction in more than 80 % of subjects. Thighs circumference change (Baseline data vs. the 30-day and 90 day-Follow Up) was statistically highly significant.
The secondary objective was absence of adverse events and subjects satisfaction with the therapy. The secondary obiective was met with no adverse events recorded and more than 80% of treated subjects reported satisfaction with the therapy at 30-day and 90 day-Follow Up.
More than 80% of treated subjects reported aesthetic appearance improvement at 30 day-Follow Up and more than 76% of treated subjects reported aesthetic appearance improvement at 90 day-Follow Up.
The statistical methods used: Two Sample t-Test: Unequal Variances and t-Test: Paired Two Sample For Means. The clinical study of XP1100 RF device supports the effectiveness of the device for temporary reduction of thighs circumference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 80 % of subjects achieved ≥1 cm thighs circumferential reduction
- More than 80% of treated subjects reported satisfaction with the therapy at 30-day and 90 day-Follow Up.
- More than 80% of treated subjects reported aesthetic appearance improvement at 30 day-Follow Up
- More than 76% of treated subjects reported aesthetic appearance improvement at 90 day-Follow Up.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
BTL Industries, Inc. c/o Michail M. Pankratov, Principal MMP Medical Associates LLC 16 Appleton St., Waltham, MA 02453
Re: K152731
Trade/Device Name: XP1100 RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulatory Class: Class II Product Code: GEI Dated: June 17, 2016 Received: June 24, 2016
Dear Mr. 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Christopher J. Ronk -A
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 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) K152731
Device Name XP1100 RF
Indications for Use (Describe) The XP1100 RF is indicated for temporary reduction in circumference of the abdomen and thighs.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| X 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: | |||
| Food and Drug Administration | |||
| Office of Chief Information Officer | |||
| Paperwork Reduction Act (PRA) Staff | |||
| PRAStaff(@fda.hhs.gov | Department of Health and Human Services |
"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."
PSC Publishing Services (301) 443-6740
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Image /page/3/Picture/0 description: The image shows a logo for an organization, possibly a company or institution. The logo consists of three interconnected blue diamond shapes. Within each diamond is a letter: "B" in the left diamond, "T" in the center diamond, and "L" in the right diamond. The letters are also in blue, matching the color of the diamond outlines.
K152731 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: | 7 September 2015 |
Device Names
| Trade/Proprietary Name: | XP1100 RF |
|---|---|
| Primary Classification Name: Electrosurgical Cutting and Coagulation Device & | Accessories |
| Classification Regulation: | 878.4400 |
| Product Code: | GEI |
Legally Marketed Predicate Devices
The XP1100 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:
- XP1000 RF (K143559) .
Product Description
The XP1100 RF system is designed for temporary reduction in circumference of the abdomen and thighs by means of high-frequency electromagnetic field. The multi-jointed
4
Image /page/4/Picture/0 description: The image shows a logo with three interconnected blue diamonds. Inside each diamond is a letter, spelling out the acronym "BTV". The letters are white and stand out against the blue background of the diamonds. The diamonds are arranged horizontally, with the "B" on the left, the "T" in the center, and the "V" on the right.
arm firmly supports the applicator during treatment. Large knobs lock and unlock the ioints 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 XP1100 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 XP1100 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 XP1100 RF is indicated for temporary reduction in circumference of the abdomen and thighs.
Non-clinical Testing
The XP1100 RF device has been thoroughly evaluated for electrical safety and performance. The XP1100 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
| 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 | General requirements for basic safety and essential performance of |
| high frequency surgical equipment and high frequency surgical | |
| accessories | |
| 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 a logo with the text "Clinical testing" underneath it. The logo consists of three blue diamond shapes that are connected to each other. The letters "B", "T", and "L" are placed inside the diamond shapes. The text "Clinical testing" is written in black font.
The XP1100 RF device was clinically tested for reduction of thighs circumference by disruption of adipocyte cells. Forty subjects (28 women, 12 men), ranging from 23 to 54 years of age, skin type in range from II to IV, race/ethnicity white, were enrolled in the open label study. Treated subjects received 4 treatment sessions (30 minutes per each leg) delivered once a week over a 4-week period.
The subjects have met the primary efficacy outcome measure by achieving ≥1 cm thighs circumferential reduction in more than 80 % of subjects. Thighs circumference change (Baseline data vs. the 30-day and 90 day-Follow Up) was statistically highly significant.
The secondary objective was absence of adverse events and subjects satisfaction with the therapy. The secondary obiective was met with no adverse events recorded and more than 80% of treated subjects reported satisfaction with the therapy at 30-day and 90 day-Follow Up.
More than 80% of treated subjects reported aesthetic appearance improvement at 30 day-Follow Up and more than 76% of treated subjects reported aesthetic appearance improvement at 90 day-Follow Up.
The statistical methods used: Two Sample t-Test: Unequal Variances and t-Test: Paired Two Sample For Means. The clinical study of XP1100 RF device supports the effectiveness of the device for temporary reduction of thighs circumference.
| 510(k) number | K152731 | K143559 |
|---|---|---|
| Device name | XP1100 RF | XP1000 RF |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code | ||
| Regulation | General & Plastic Surgery | |
| 21 CFR 878.4400 | ||
| -GEI, Electrosurgical | ||
| Cutting and Coagulation | ||
| Device & Accessories. | General & Plastic Surgery | |
| 21 CFR 878.4400 | ||
| -GEI, Electrosurgical | ||
| Cutting and Coagulation | ||
| Device & Accessories. | ||
| Intended Use | Non-invasive radiofrequency | |
| body shaping device. | Non-invasive radiofrequency | |
| body shaping device. | ||
| Indications for | ||
| Use | The XP1100 RF is indicated | |
| for temporary reduction in | ||
| circumference of the | ||
| abdomen and thighs. | The XP1000 RF is indicated | |
| for temporary reduction in | ||
| circumference of the | ||
| abdomen. | ||
| Deep tissue | ||
| Heating | ||
| Electromagnetic | ||
| Energy | Radiofrequency | Radiofrequency |
| 510(k) number | K152731 | K143559 |
| Device name | XP1100 RF | XP1000 RF |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Electrical | ||
| Protection | Class II, BF | Class II, 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 an | ||
| applicator utilized to deliver | ||
| the treatment. | ||
| Color Touch | ||
| Screen | 8.4 in | |
| 21.5 cm | ||
| 640×480 pixel | 8.4 in | |
| 21.5 cm | ||
| 640×480 pixel | ||
| Modes Of | ||
| Operation | Bipolar | Bipolar |
| Nominal | ||
| Operating | ||
| Power | Max: 200 W RF | Max: 200 W RF |
| RF Carrier | ||
| Frequency | 27.12 MHz (±400 kHz) | 27.12 MHz (±400 kHz) |
| Operating | ||
| Temperature | 10-30 °C | 10-30 °C |
| Operating | ||
| Humidity | 30-75 % | 30-75 % |
| Skin | ||
| Temperature | ||
| Monitoring | Based on patient's feedback. | |
| External IR thermometer. | Based on patient's feedback. | |
| External IR thermometer. | ||
| Treatment | ||
| Temperature | ||
| Range | 40-45 °C | 40-45 °C |
| Applicator | ||
| Holder | ||
| Availability | YES | YES |
| Waveform | Sinusoid | Sinusoid |
| Applicator | ||
| Models | AB, EX | AB |
| Applicators | ||
| Effective | ||
| Area | AB: 201.06 cm² | |
| EX: 320.00 cm² | AB: 201.06 cm² | |
| 510(k) number | K152731 | K143559 |
| Device name | XP1100 RF | XP1000 RF |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Treatment Time | Up to 45 min using AB applicator, up to 30 min using EX applicator | Up to 45 min |
| Total Energy | ||
| Density | AB: 0.994 W/cm² | |
| EX: 0.625 W/cm² | AB: 0.994 W/cm² | |
| Material of the | ||
| Generator Case | Plastic/metal | Plastic/metal |
| RF Energy | ||
| Emission | ||
| Indicator | YES; Information displayed on the screen of the unit | YES; Information displayed on the screen of the unit |
| AB Applicator | ||
| Weight | 3.9 lbs (1760 g) | 3.9 lbs (1760 g) |
| EX Applicator | ||
| Weight | 2.8 lbs (1260 g) | n/a |
| AB Applicator | ||
| Dimensions | 686×192×105 mm | |
| (27×7.6×4.1 in) | 686×192×105 mm | |
| (27×7.6×4.1 in) | ||
| EX Applicator | ||
| Dimensions | 732×287×124 mm | |
| (28×11,3×4,8 in) | n/a | |
| Energy Source | 100–240 VAC, max 5 A, | |
| 50–60 Hz | 100–240 VAC, max 5 A, | |
| 50–60 Hz | ||
| External | ||
| Exchangeable | ||
| Fuse | T6.3 AL / 250 V, tube safety fuse 5×20 mm | |
| (for supply voltage ~ 100 V to 120 V) | T6.3 AL / 250 V, tube safety fuse 5×20 mm | |
| (for supply voltage ~ 100 V to 120 V) | ||
| System | ||
| Dimensions | 560×980×560 mm | |
| (22×39×22 in) | 560×980×560 mm | |
| (22×39×22 in) | ||
| System Weight | 84 lbs (38 kg) | 84 lbs (38 kg) |
Comparison with the Predicate Device
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Image /page/6/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are inside of three diamond shapes that are connected to each other. The logo is blue and the background is white.
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Image /page/7/Picture/0 description: The image shows a logo with three interconnected blue squares. The letters "B", "T", and "L" are placed inside each of the squares respectively. The logo is simple and modern, with a clean design.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the XP1100 RF device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusion
Based on the aforementioned information, the XP1100 RF is substantially equivalent to the identified predicate device.