(174 days)
BTL-899 (K192224)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing, or descriptions of training/test sets, which are common indicators of AI/ML in medical devices. The device description focuses on user interface and basic therapeutic parameter setting.
Yes
The device description explicitly states, "The BTL-899ST is a non-invasive therapeutic device." Additionally, its intended use for "non-invasive lipolysis" and "reduction in circumference" also describes a therapeutic function.
No
The device is described as a "non-invasive therapeutic device" for lipolysis and circumference reduction, indicating treatment rather than diagnosis.
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 a "Total Stop Button," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the BTL-899ST device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Non-invasive lipolysis (breakdown of fat)" and "Reduction in circumference" of the abdomen and thighs. These are therapeutic and aesthetic purposes, not diagnostic testing performed on samples taken from the body.
- Device Description: The description details a non-invasive therapeutic device with applicators that deliver treatment externally. It does not mention any components for collecting or analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The BTL-899ST is a therapeutic device used for body contouring and fat reduction through non-invasive means.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The BTL-899ST is a non-invasive therapeutic device.
BTL-899ST 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 the Total Stop Button to terminate the device. The Total Stop Button is located on the rear panel of the main unit. 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)
Study type: Two-arm, open-label, interventional study
Sample size: N=40 subjects were enrolled/treated in the study to be treated with BTL-899ST. N=29 subjects received treatment with the device and completed the 1-month follow-up and 38 subjects in total respected the 3- months follow-up and were examined and interviewed for possible adverse events. 29 subjects completed follow-up.
Key results:
- The primary efficacy outcome measure was a minimum of 80% of subjects at 30-day follow-up evaluation to show thighs mean circumference reduction of ≥ 1 cm relative to the baseline assessment. Twenty-two of the twenty-nine subjects responded to treatment with the subject device. Forty-seven of the total 58 thighs treated had circumference reduction of ≤ 1 cm at 1-month follow-up relative to the baseline assessment.
- All the twenty-nine subjects were either satisfied (9) or very satisfied (20) with the treatment results.
- The participants also rated the improvement of their thighs at 1-month follow-up, with results leaning towards much improved.
- The secondary endpoint was met with 100% of the participants in this satisfied with the therapy results. Furthermore, 90% of the subjects judged that the appearance of their thighs has been improved.
- All the subjects found the therapy comfortable. Eight participants (28%) agreed and 21 (72%) strongly agreed with the statement "I found the treatment comfortable".
- A pain rating scale ranging from zero (no pain) to 10 (worst possible pain) was used. Ten persons (34%) reported weak pain. Nineteen subjects (66%) reported no pain at all by choosing a score of zero.
- One adverse event was recorded. A participant in ARM 1 was diagnosed with panniculitis on the inner side of one of the thighs. The AE was judged as related to the treatment and was mild.
- Based on the clinical data of above mentioned clinical study, the BTL-899ST device demonstrated acceptable performance and safety profile of the device for non-invasive lipolysis and circumference reduction of thighs. Results further support substantial equivalence of the subject device compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
BTL-899 (K192224)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2021
BTL David Chmel Vice President of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K202199
Trade/Device Name: BTL-899ST Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 15, 2020 Received: December 18, 2020
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.
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
1
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 (OS) 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 mediation-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
2
Indications for Use
510(k) Number (if known) K202199
Device Name BTL-899ST
Indications for Use (Describe)
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.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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 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 dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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 | |
Device Name
Date:
| Trade/Proprietary Name: | BTL-899ST |
|---|---|
| Primary Classification Name: | Electrosurgical, Cutting & Coagulation Device & Accessories |
| Classification Regulation: | 878.4400, Class II |
| Classification Product Code: | GEI |
26 January 2020
Legally Marketed Predicate Device
The BTL-899ST 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-899 (K192224)
4
Product Description
Image /page/4/Picture/2 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL". 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.
The BTL-899ST is a non-invasive therapeutic device.
BTL-899ST 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 the Total Stop Button to terminate the device. The Total Stop Button is located on the rear panel of the main unit. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators.
Indications for Use
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.
Non-clinical Testing (Performance, Bench Testing)
The BTL-899ST 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 |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization |
5
Clinical Testing
Image /page/5/Picture/2 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 gray. The font used for "Industries" is a sans-serif font with a futuristic look.
A clinical study has been conducted to demonstrate the performance, clinical efficacy and safety of the BTL-899ST device for non-invasive lipolysis and circumference reduction of thighs. The treatment with the BTL-899 device has shown to be both effective and safe for non-invasive lipolysis and circumference reduction of the thighs.
In total, N=40 subjects were enrolled/treated in the study to be treated with BTL-899ST. N=29 subjects received treatment with the device and completed the 1-month follow-up and 38 subjects in total respected the 3- months follow-up and were examined and interviewed for possible adverse events.
All the subjects were female (average age 40.26) with 17 Fitzpatrick Skin Type (FST) II and 9 with FST III, and with 3 subjects having FST IV.
The primary efficacy outcome measure was a minimum of 80% of subjects at 30-day follow-up evaluation to show thighs mean circumference reduction of ≥ 1 cm relative to the baseline assessment.
Twenty-two of the twenty-nine subjects responded to treatment with the subject device. Forty-seven of the total 58 thighs treated had circumference reduction of ≤ 1 cm at 1-month follow-up relative to the baseline assessment.
All the twenty-nine subjects were either satisfied (9) or very satisfied (20) with the treatment results.
The participants also rated the improvement of their thighs at 1-month follow-up, with results leaning towards much improved.
The secondary endpoint was met with 100% of the participants in this satisfied with the therapy results. Furthermore, 90% of the subjects judged that the appearance of their thighs has been improved.
All the subjects found the therapy comfortable. Eight participants (28%) agreed and 21 (72%) strongly agreed with the statement "I found the treatment comfortable".
A pain rating scale ranging from zero (no pain) to 10 (worst possible pain) was used. Ten persons (34%) reported weak pain. Nineteen subjects (66%) reported no pain at all by choosing a score of zero.
6
Image /page/6/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. The logo appears to be for a company in the industrial sector.
The below table is a summary of the study design and results:
| Study design | Two-arm, open-label, interventional study |
|---|---|
| Sample size- | 29 subjects completed follow-up |
| Number of treatments | |
| and follow-up visits | 4 treatments and 2 follow-up visits at 30 and 90 days. |
| Primary endpoints | The primary efficacy outcome measure was a minimum of 80% of subjects |
| at 30-day follow-up evaluation to show mean thighs circumference | |
| reduction of $\ge$ 1 cm relative to the baseline assessment. | |
| Secondary endpoints | Evaluation of the safety of the BTL-899 device for non-invasive lipolysis |
| (breakdown of fat) of the thighs. | |
| Minimum 80% of treated subjects to report satisfaction (level satisfied and | |
| higher) with the therapy. | |
| Efficacy Results | Twenty-two of the 29 subjects responded to treatment with the subject |
| device. Forty-seven of the total 58 thighs treated had circumference | |
| reduction of $\le$ 1 cm at 1-month follow-up relative to the baseline | |
| assessment. | |
| Safety results | One adverse event was recorded. A participant in ARM 1 was diagnosed |
| with panniculitis on the inner side of one of the thighs. The AE was judged as | |
| related to the treatment and was mild. |
In conclusion, treatment with the BTL-899ST device has shown to be both effective and safe for noninvasive lipolysis and circumference reduction of thighs.
Based on the clinical data of above mentioned clinical study, the BTL-899ST device demonstrated acceptable performance and safety profile of the device for non-invasive lipolysis and circumference reduction of thighs. Results further support substantial equivalence of the subject device compared to the predicate device.
Technological Characteristics
The BTL-899ST device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899ST 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.
7
Image /page/7/Picture/1 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 logo is the text "BTL Industries" in a gray, sans-serif font.
The mechanism of action and technological similarities and differences between the BTL-899ST 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.
Comparison with the Predicate Device
| 510(k) number | K202199 | K192224 | Significant Difference |
|---|---|---|---|
| Device name | BTL-899ST | BTL-899 | |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | |
| 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-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. | BTL-899 is indicated to be used | ||
| for: | |||
| • Non-invasive lipolysis | |||
| (breakdown of fat) of the | |||
| abdomen. | |||
| • Reduction in circumference of | |||
| the abdomen | |||
| • The BTL-899 is intended for | |||
| use with Skin Type I to Skin | |||
| Type 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 outputs | |||
| 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 | |||
| (Intensity, Time) | 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 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | None |
| System | 23 x 39 x 29 in | 23 x 39 x 29 in | None |
| Dimensions | |||
| (W×H×D) | (592 x 985 x 730 mm) | (592 x 985 x 730 mm) | |
| System Weight | 85 kg | 85 kg | None |
| Operating Ambient | |||
| Temperature | +10°C to +30°C | +10°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 |
8
Image /page/8/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three nested blue squares on the left side of the image. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
9
Image /page/9/Picture/1 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 squares, each nested inside the other, with the letters "BTL" inside the innermost square.
Substantial Equivalence
The BTL-899ST device has expanded indications for use to include the thighs area.
There are no technological modifications done to the device and its applicator compared to the predicate device.
The Sponsor of this 510(k) submission has conducted a clinical study and based on the positive results achieved in the study the new indications have been added. Additionally, the safety of the device has been evaluated in the study and no new risks have been identified.
Therefore this difference does 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-899ST device has been shown to be substantially equivalent to the currently marketed predicate device.