(86 days)
Not Found
No
The summary describes a non-invasive therapeutic device using radiofrequency and electromagnetic stimulation with a touch screen interface for setting parameters. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or parameter adjustment.
Yes.
The device description explicitly states, "The BTL-899 FP is a non-invasive therapeutic device." Additionally, its intended use includes "non-invasive lipolysis" and "reduction in circumference," which are therapeutic actions.
No
The device description explicitly states it is a "non-invasive therapeutic device" and its intended uses are for lipolysis and circumference reduction, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it consists of a "main unit and applicator(s)" and describes physical components like a "color touch screen" and "emergency button," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure (non-invasive lipolysis and circumference reduction) performed directly on the patient's body (abdomen and thighs). IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment decisions.
- Device Description: The device description details a therapeutic device with applicators that deliver energy to the body. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Anatomical Site: The device is applied to specific anatomical sites on the patient's body. IVDs work with samples taken from the body.
- Performance Studies: The performance studies focus on clinical efficacy and safety of the treatment on subjects, measuring outcomes like fat thickness reduction and circumference reduction. IVD performance studies would focus on the accuracy and reliability of the diagnostic results obtained from analyzing samples.
In summary, the BTL-899 FP is a therapeutic device used for body contouring, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
BTL-899 FP is indicated to be used for:
- · Non-invasive lipolysis (breakdown of fat) of the abdomen.
- · Reduction in circumference of the abdomen.
- · Non-invasive lipolysis (breakdown of fat) of the thighs.
- · Reduction in circumference of the thighs.
- · BTL-899 FP is intended for use with skin type I - VI.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The BTL-899 FP is a non-invasive therapeutic device.
BTL-899 FP consists of a main unit and applicator(s). The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Clinical Testing
Study Type: Clinical investigations
Sample Size: 34 subjects with Fitzpatrick Skin Types (FST) IV-VI for efficacy and safety; 9 subjects with skin type IV, 8 subjects with skin type V and 8 subjects with skin type VI finished three active 30-minute treatments.
Key Results:
The primary endpoint in subjects with FST IV-VI, who underwent active treatments with the BTL-899 FP device has been met. All subjects exhibited reduction in the fat thickness in their abdominal area, matching the efficacy previously evidenced in the 510(k) K192224. Circumference reduction was seen in 75% of subjects in total.
The secondary endpoint of the study, subjects' satisfaction with the therapy, has also been met with 88% of the subjects satisfied with the achieved results. Subjects felt none (92%) to minimal (8%) discomfort during the study treatment.
No adverse events were reported in the course of the clinical investigations and in particular in the subjects with FST IV-VI. There was no inflammation or post-inflammatory hyperpigmentation in the treated areas immediately after the treatments or at the follow-up visits. The only observed side effects related to the therapy were mild erythema and muscle soreness that occur in FST I-III subjects as well. These resolved very quickly for all subjects.
In conclusion, the treatments with BTL-899 FP have proven to be safe for patients with Fitzpatrick skin types I to VI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Circumference reduction was seen in 75% of subjects.
Subject satisfaction: 88% of subjects satisfied.
Discomfort level: 92% felt none, 8% felt minimal.
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.
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July 9, 2021
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K211107
Trade/Device Name: BTL-899 FP Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 12, 2021 Received: May 17, 2021
Dear David 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211107
Device Name BTL-899 FP
Indications for Use (Describe)
BTL-899 FP is indicated to be used for:
- · Non-invasive lipolysis (breakdown of fat) of the abdomen.
- · Reduction in circumference of the abdomen.
- · Non-invasive lipolysis (breakdown of fat) of the thighs.
- · Reduction in circumference of the thighs.
- · BTL-899 FP is intended for use with skin type I VI.
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)
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Image /page/3/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the logo is the text "BTL Industries" in a gray, sans-serif font. The text is aligned horizontally with the logo.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
Date: | 07 April 2021 |
Device Name
| Trade/Proprietary Name: | BTL-899 FP |
|---|---|
| Primary Classification Name: | Electrosurgical, Cutting & Coagulation Device & Accessories |
| Classification Regulation: | 878.4400, Class II |
| Classification Product Code: | GEI |
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font.
Legally Marketed Predicate Device
The BTL-899 FP 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 distribution in the USA under the following 510(k) Premarket Notification numbers:
- BTL-899ST (K202199) ●
Product Description
The BTL-899 FP is a non-invasive therapeutic device.
BTL-899 FP consists of a main unit and applicator(s). The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators.
Indications for Use
BTL-899 FP is indicated to be used for:
- Non-invasive lipolysis (breakdown of fat) of the abdomen. ●
- . Reduction in circumference of the abdomen.
- Non-invasive lipolysis (breakdown of fat) of the thighs.
- . Reduction in circumference of the thighs.
- . BTL-899 FP is intended for use with skin types I - VI.
Non-clinical Testing (Performance, Bench Testing)
The BTL-899 FP device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances
– Requirements and tests |
| IEC 62304 | Medical device software - Software life cycle processes |
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested diamond shapes in blue, with the letters "BTL" inside the innermost diamond. To the right of the diamond shapes is the text "BTL Industries" in a gray sans-serif font.
- Medical devices Application of risk management to medical devices ISO 14971
- ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-5
- ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Clinical Testing
BTL Industries conducted two clinical investigations in the United States of America.
In total 34 subjects with Fitzpatrick Skin Types (FST) IV-VI were recruited to participate in the two IRBapproved clinical studies investigating clinical efficacy and safety of the BTL-899 FP device for toning of abdomen and reduction of subcutaneous fat.
In summary 9 subjects with skin type IV, 8 subjects with skin type V and 8 subjects with skin type VI finished three active 30-minute treatments with BTL-899 FP device spaced 1 week apart. Average BMI of all subjects was 27.7±3.3 kg·m2. They were scheduled to 1-month, 3-month and 6-month follow-up (optional) visits and examined for adverse reactions to the treatment, fat tissue reduction (by diagnostic ultrasound or magnetic resonance), abdominal circumference reduction, therapy comfort (using 5-point Likert scale questionnaire and 10-point visual analogue scale - VAS) and subjective satisfaction (using 5-point Likert scale questionnaire).
The primary endpoint in subjects with FST IV-VI, who underwent active treatments with the BTL-899 FP device has been met. All subjects exhibited reduction in the fat thickness in their abdominal area, matching the efficacy previously evidenced in the 510(k) K192224. Circumference reduction was seen in 75% of subjects in total.
The secondary endpoint of the study, subjects' satisfaction with the therapy, has also been met with 88% of the subjects satisfied with the achieved results. Subjects felt none (92%) to minimal (8%) discomfort during the study treatment.
No adverse events were reported in the course of the clinical investigations and in particular in the subjects with FST IV-VI. There was no inflammation or post-inflammatory hyperpigmentation in the treated areas immediately after the treatments or at the follow-up visits. The only observed side effects related to the therapy were mild erythema and muscle soreness that occur in FST I-III subjects as well. These resolved very quickly for all subjects.
In conclusion, the treatments with BTL-899 FP have proven to be safe for patients with Fitzpatrick skin types I to VI.
Technological Characteristics
The BTL-899 FP device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899 FP device and its predicate are comprised of a system console and applicator(s). The system console consists of the generators, computer, and the touch-screen control panel.
The mechanism of action and technological similarities and differences between the BTL-899 FP device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares, with the letters "BTL" inside the innermost square. To the right of the square logo is the text "BTL Industries" in a simple, sans-serif font. The logo and text are both in a dark gray color.
Comparison with the Predicate Device
| 510(k) number
Device name
Company name | Not assigned
BTL-899 FP
BTL Industries, Inc. | K202199
BTL-899ST
BTL Industries, Inc. | Significant
Difference |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Product Code
and Regulation | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical, Cutting &
Coagulation & Accessories | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical, Cutting &
Coagulation & Accessories | None |
| Indications for Use | BTL-899 FP is indicated to be used
for:
· Non-invasive lipolysis
(breakdown of fat) of the
abdomen.
• Reduction in circumference of
the abdomen
· Non-invasive lipolysis
(breakdown of fat) of the thighs.
• Reduction in circumference of
the thighs.
• BTL-899 FP is intended for use
with skin types I - VI. | BTL-899ST is indicated to be
used for:
· Non-invasive lipolysis
(breakdown of fat) of the
abdomen.
• Reduction in circumference of
the abdomen
· Non-invasive lipolysis
(breakdown of fat) of the
thighs.
· Reduction in circumference of
the thighs.
• BTL-899ST is intended for
use with Skin Type I, II and
III. | Not
significantly
different |
| Basic Technology | The system combines bipolar
radiofrequency with
electromagnetic stimulation. | The system combines bipolar
radiofrequency with
electromagnetic stimulation. | None |
| Clinical Use | Prescription use | Prescription use | None |
| Electrical Protection | Class II, BF | Class II, BF | None |
| User Interface | Touch screen | Touch screen | None |
| Firmware Controlled | Yes | Yes | None |
| Number of output
channels | 2 | 2 | None |
| RF Type | bipolar | bipolar | None |
| Max. RF Power | 60 W (2x30 W) | 60 W (2x30 W) | None |
| RF Frequency | 27.12 Mhz | 27.12 Mhz | None |
| Number of Magnetic
coils in the
Applicator | 1 | 1 | None |
| Magnetic Field
Intensity (on the coil
surface) | 0.5 to 1.8 T | 0.5 to 1.8 T | None |
| Pulse Repetition
Rate - supported by
the device | 1 – 150 Hz | 1 – 150 Hz | None |
| Pulse Duration | 280 µs ± 20% µs | 280 µs ± 20% µs | None |
| Waveform | Biphasic | Biphasic | None |
| Shape | Sinusoidal | Sinusoidal | None |
| Temperature Sensor | Yes | Yes | None |
| Selection of
parameters | Yes | Yes | None |
| Application | Hands-free, applicator fixed by
fixation belt | Hands-free, applicator fixed by
fixation belt | None |
| Therapy Time | Up to 30 min | Up to 30 min | None |
| Energy Source | 100 V to 230 V AC, 50 Hz
100 V to 130 V AC, 60 Hz | 100 V to 230 V AC, 50 Hz
100 V to 130 V AC, 60 Hz | None |
| System Dimensions
(W×H×D) | 23 x 39 x 29 in
(592 x 985 x 730 mm) | 23 x 39 x 29 in
(592 x 985 x 730 mm) | None |
| System Weight | 155 lb (70 kg) / 200 lb (91 kg)
including packaging and accessories | 155 lb (70 kg) / 200 lb (91 kg)
including packaging and
accessories | None |
| Operating Ambient
Temperature | 64 °F to 86 °F
(+18 °C to +30 °C) | 64 °F to 86 °F
(+18 °C to +30 °C) | None |
| Operating Relative
Humidity | 30% to 75% | 30% to 75% | None |
| Environmental
Specifications | For indoor use only | For indoor use only | None |
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three interlocking squares, each with the letters "B", "T", and "L" inside. The text "BTL Industries" is written in a dark gray sans-serif font.
Substantial Equivalence
The BTL-899 FP device has expanded indications for use to include Fitzpatrick Skin Types I - VI.
There are no technological modifications done to the device and its applicator compared to the predicate device.
The safety of the device has been evaluated and no new risks have been identified.
Therefore these differences do not raise any new questions of safety or effectiveness.
Conclusion
Based upon the intended use and the known technical and clinical data provided in this pre-market notification, the BTL-899 FP device has been shown to be substantially equivalent to the currently marketed predicate device.