(86 days)
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.
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. The system combines bipolar radiofrequency with electromagnetic stimulation.
Here's a summary of the acceptance criteria and study details for the BTL-899 FP device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the BTL-899 FP device. Instead, it describes "endpoints" for its clinical studies focusing on safety and efficacy, which can be interpreted as the criteria for demonstrating the device's performance. The performance is compared to what was "previously evidenced" by a predicate device.
| Acceptance Criterion (Clinical Endpoint) | Reported Device Performance |
|---|---|
| Primary Endpoint (Efficacy): Reduction in fat thickness in the abdominal area (for FST IV-VI subjects) | 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. |
| Secondary Endpoint (Satisfaction): Subjects' satisfaction with the therapy | 88% of subjects were satisfied with the achieved results. |
| Safety: Absence of adverse events, discomfort, inflammation, or post-inflammatory hyperpigmentation. | No adverse events were reported, particularly in subjects with FST IV-VI. Subjects felt none (92%) to minimal (8%) discomfort. No inflammation or post-inflammatory hyperpigmentation was observed immediately after treatment or at follow-up. Mild erythema and muscle soreness were observed (resolved quickly). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 34 subjects with Fitzpatrick Skin Types (FST) IV-VI were recruited.
- Specific breakdown: 9 subjects with skin type IV, 8 subjects with skin type V, and 8 subjects with skin type VI completed the treatments (25 subjects explicitly mentioned as completing, though 34 recruited).
- Data Provenance: Prospective, clinical investigations conducted in the United States of America.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical endpoints (fat thickness reduction, circumference reduction, satisfaction, safety). The assessment appears to be based on direct measurements (ultrasound or MRI for fat/circumference) and patient self-reporting (Likert scale, VAS for discomfort and satisfaction). There is no mention of independent expert review of these assessments.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the clinical study results. Measurements appear to be taken directly or reported by subjects, with no indication of a separate expert review or consensus process for conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly done. The study focused on the performance of the BTL-899 FP device itself, primarily comparing it to "efficacy previously evidenced" by its predicate device (K192224), rather than comparing human readers with and without AI assistance. The BTL-899 FP is a therapeutic device, not an AI diagnostic/interpretive tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. The BTL-899 FP is a physical therapeutic device with specific operational parameters, not an algorithm, AI, or software that can operate in a standalone manner without human interaction. The "algorithm" in this context refers to the device's internal firmware controlling the treatment, not an AI for interpretation or diagnosis.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through:
- Objective Measurements: Diagnostic ultrasound or magnetic resonance for fat tissue reduction, and abdominal circumference measurements.
- Patient-Reported Outcomes: 5-point Likert scale questionnaire and 10-point visual analogue scale (VAS) for therapy comfort and subjective satisfaction.
- Observation/Clinical Assessment: Monitoring for adverse reactions (inflammation, post-inflammatory hyperpigmentation, erythema, muscle soreness).
8. The Sample Size for the Training Set
The device is a physical therapeutic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device's parameters comes from pre-clinical engineering, safety testing, and potentially prior clinical studies that informed the predicate device's efficacy. The document does not describe a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
As stated above, this question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth labels. The performance of the device's internal control firmware is evaluated through engineering verification and validation against safety and performance standards (e.g., IEC 60601-1, IEC 62304) and confirmed safe and effective via a clinical study with real subjects.
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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.
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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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510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Summary PreparationDate: | 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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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 safetyand essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic disturbances– Requirements and tests |
| IEC 62304 | Medical device software - Software life cycle processes |
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- 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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Comparison with the Predicate Device
| 510(k) numberDevice nameCompany name | Not assignedBTL-899 FPBTL Industries, Inc. | K202199BTL-899STBTL Industries, Inc. | SignificantDifference |
|---|---|---|---|
| Product Codeand Regulation | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & Accessories | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & Accessories | None |
| Indications for Use | BTL-899 FP is indicated to be usedfor:· Non-invasive lipolysis(breakdown of fat) of theabdomen.• Reduction in circumference ofthe abdomen· Non-invasive lipolysis(breakdown of fat) of the thighs.• Reduction in circumference ofthe thighs.• BTL-899 FP is intended for usewith skin types I - VI. | BTL-899ST is indicated to beused for:· Non-invasive lipolysis(breakdown of fat) of theabdomen.• Reduction in circumference ofthe abdomen· Non-invasive lipolysis(breakdown of fat) of thethighs.· Reduction in circumference ofthe thighs.• BTL-899ST is intended foruse with Skin Type I, II andIII. | Notsignificantlydifferent |
| Basic Technology | The system combines bipolarradiofrequency withelectromagnetic stimulation. | The system combines bipolarradiofrequency withelectromagnetic 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 outputchannels | 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 Magneticcoils in theApplicator | 1 | 1 | None |
| Magnetic FieldIntensity (on the coilsurface) | 0.5 to 1.8 T | 0.5 to 1.8 T | None |
| Pulse RepetitionRate - supported bythe 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 ofparameters | Yes | Yes | None |
| Application | Hands-free, applicator fixed byfixation belt | Hands-free, applicator fixed byfixation belt | None |
| Therapy Time | Up to 30 min | Up to 30 min | None |
| Energy Source | 100 V to 230 V AC, 50 Hz100 V to 130 V AC, 60 Hz | 100 V to 230 V AC, 50 Hz100 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 andaccessories | None |
| Operating AmbientTemperature | 64 °F to 86 °F(+18 °C to +30 °C) | 64 °F to 86 °F(+18 °C to +30 °C) | None |
| Operating RelativeHumidity | 30% to 75% | 30% to 75% | None |
| EnvironmentalSpecifications | 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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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.
§ 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.