(212 days)
BTL-899F 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-899F is intended for use with skin types I VI.
- Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV.
- Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
The BTL-899F is a non-invasive therapeutic device.
BTL-899F consists of a main unit and applicators. 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.
The provided text describes a 510(k) premarket notification for the BTL-899F device, a non-invasive therapeutic device intended for lipolysis and circumference reduction in various body areas. The submission aims to demonstrate substantial equivalence to a predicate device (BTL-899A).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Objective) | Reported Device Performance |
|---|---|
| Mean population reduction of flanks' fat thickness pre- vs 3-months post-treatment | 5 mm reduction in the mean fat thickness (measured by ultrasound) |
| Acceptance Criterion (Secondary Objectives) | Reported Device Performance |
|---|---|
| Safety of the device (non-invasive lipolysis of flanks) | Considered safe. Only one anticipated side effect reported: mild erythema in one patient, lasting 1 hour after the second procedure, which resolved without medical intervention (erythema is an expected and declared side effect). |
| Minimum 75% of subjects' pre-treatment and 3-month follow-up post-treatment images correctly identified by at least two of three independent blinded evaluators. | Rate of successful recognition of the subject's pre-/post-treatment photographs was 88.2%. All three independent blinded evaluators identified images with more than 75% accuracy. |
| Participants' satisfaction and comfort level | All participants found the procedure comfortable and virtually painless, agreeing or strongly agreeing with comfort levels. All were satisfied or very satisfied with the procedure at 3-month follow-up. All reported improved, much improved, or very much improved appearance of the flanks area at 3-month follow-up. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 55 subjects were enrolled in the study. 51 participants attended the final 3-month follow-up. The performance metrics are based on these 51 participants.
- Data Provenance: The document does not explicitly state the country of origin for the data. It is a clinical investigation conducted by BTL Industries Inc., a company with a Marlborough, Massachusetts address. The study design is described as single-arm, open-label, and interventional, indicating it was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three independent blinded evaluators were used to assess the pre- and post-treatment images.
- Qualifications of Experts: The document does not specify the qualifications (e.g., radiologist with years of experience) of the evaluators. They are simply referred to as "independent blinded evaluators."
4. Adjudication Method for the Test Set
- The acceptance criterion for image identification was "at least two of three independent blinded evaluators." This implies a 2 out of 3 consensus or similar majority-based adjudication method for image recognition. The exact adjudication method for other observations (e.g., fat thickness measurement, side effect assessment) is not explicitly detailed, but the fat thickness reduction seems to be a measured outcome, not subjected to expert adjudication in the same way.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not conducted. This study's primary focus was on the device's direct effect on fat thickness and subjective patient outcomes, with independent evaluators assessing before/after images. The device itself is a therapeutic device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a therapeutic device (electrosurgical cutting and coagulation device) that performs non-invasive lipolysis. It is not an AI algorithm in the context of image analysis or diagnostic support. Therefore, a "standalone algorithm performance" evaluation as typically understood for AI software was not applicable and not performed. The device's performance is driven by its physical application and effect.
7. The Type of Ground Truth Used
- The ground truth for the primary objective (fat thickness reduction) was based on objective measurements (ultrasound).
- For the secondary objectives:
- Safety was assessed through clinical observation and patient reporting of adverse events.
- Image evaluation involved a form of expert consensus (at least 2 out of 3 independent blinded evaluators).
- Patient satisfaction and comfort were based on patient-reported outcomes.
8. The Sample Size for the Training Set
- The document does not describe a separate "training set" in the context of an AI model. The clinical investigation appears to be a single study evaluating the device's performance. The device is a physical therapeutic device, not a software algorithm that would typically undergo a separate training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a separate training set for an AI model, this question is not applicable based on the provided document. The device's validation is based on the clinical investigation described for its performance.
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September 21, 2023
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K230467
Trade/Device Name: BTL-899F Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 17, 2023 Received: August 23, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.09.21 13:17:11 -04'00'
Mark Trumbore, 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) K230467
Device Name BTL-899F
Indications for Use (Describe)
BTL-899F 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-899F is intended for use with skin types I VI.
- · Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV.
- · Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| and the control control control of the control of the control of |
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 shows the logo for BTL Industries. The logo consists of a blue geometric shape with the letters "BTL" inside, followed by the words "BTL Industries" in a gray, sans-serif font. The text "K230467" is located in the upper left corner of the image.
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 | September 20, 2023 |
Device Name
| Trade/Proprietary Name: | BTL-899F |
|---|---|
| Primary Classification Name: | Electrosurgical, Cutting & Coagulation Device & Accessories |
| Classification Regulation: | 878.4400, Class II |
| Classification Product Code: | GEI |
Legally Marketed Predicate Device
The BTL-899F 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-899A (K213344) .
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Image /page/4/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.
Product Description
The BTL-899F is a non-invasive therapeutic device.
BTL-899F consists of a main unit and applicators. 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.
Indications for Use
BTL-899F 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-899F is intended for use with skin types I - VI.
- Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV.
- Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and ● BMI 30 and under.
Non-clinical Testing (Performance, Bench Testing)
The BTL-899F 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 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 withina 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 skinsensitization |
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Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside each other. The letters "BTL" are written inside the innermost square. To the right of the squares, the words "BTL Industries" are written in gray.
Clinical Testing
A clinical investigation has been conducted in order to study the effect of the device for non-invasive lipolysis on human flanks.
The primary objective of the study was to gather clinical evidence that the BTL-899 device, equipped with applicators 899-AP-C-4 & 899-AP-C-5, is capable of inducing non-invasive lipolysis on human flanks. A mean population reduction of flanks' fat thickness pre- vs 3-months post-treatment had to be observed.
The secondary objectives of the study were to evaluate the safety of the BTL-899 device for non-invasive lipolysis (breakdown of fat) of the flanks as well as to assess the participants' satisfaction and level of comfort. A minimum 75% of the subjects' pre-treatment and 3-month follow-up post-treatment images had to be correctly identified by at least two of three independent blinded evaluators.
The clinical investigation used a single-arm, open-label, interventional design. Fifty-five (55) subjects were enrolled to the study. Fifty-one (51) participants attended the final 3-month follow-up.
A mean population reduction of flanks' fat thickness pre- vs 3 months post-treatment was observed and the results showed 5 mm reduction in the mean fat thickness.
The primary endpoint was met.
-
The average fat thickness reduction measured by the ultrasound was 5 mm
The secondary endpoints were met. -
The procedure with the device for non-invasive lipolysis of flanks was considered as safe. Only one anticipated side effect of the procedure was observed in one patient: A participant reported mild erythema lasting 1 hour after the second procedure that resolved itself without medical intervention. Erythema is an expected and declared side effect in the operator's manual due to the nature of the technology used for the procedure.
-
All three independent blinded evaluators identified pre-treatment and 3-month follow-up images ● with more than 75% accuracy. The rate of successful recognition of the subject's pre-/post treatment photographs was 88.2%.
-
. The procedure was found comfortable and virtually painless. All the participants in the trial agreed or strongly agreed with the procedures being comfortable. All the participants were satisfied or very satisfied with the procedure at the 3-month follow-up. All the participants reported improved, much improved, or very much improved appearance of the flanks area at the 3-month follow-up.
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Image /page/6/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each nested inside the 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.
Technological Characteristics
The BTL-899F device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899F 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-899F 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
| Predicate device | Subject device | |
|---|---|---|
| 510(k) numberDevice name | K213344BTL-899A | K230467BTL-899F |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Codeand Regulation | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & Accessories | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & Accessories |
| Indications for Use | BTL-899A 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 thethighs.• Reduction in circumference ofthe thighs.• BTL-899A is intended for usewith skin types I - VI.• Non-invasive lipolysis(breakdown of fat) of the upperarms limited to skin types IIand III and BMI 30 and under | BTL-899F is indicated to beused for:• Non-invasive lipolysis(breakdown of fat) of theabdomen.• Reduction incircumference of theabdomen.• Non-invasive lipolysis(breakdown of fat) of thethighs.• Reduction incircumference of thethighs.• BTL-899F is intended foruse with skin types I – VI.• Non-invasive lipolysis(breakdown of fat) of theflanks limited to skin typesI - IV.• Non-invasive lipolysis(breakdown of fat) of theupper arms limited to skin |
| types II and III and BMI 30and under | ||
| Basic Technology | The system combines bipolarradiofrequency withelectromagnetic stimulation. | The system combines bipolarradiofrequency withelectromagnetic stimulation. |
| Clinical Use | Prescription use | Prescription use |
| ElectricalProtection | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen |
| FirmwareControlled | Yes | Yes |
| Number of outputchannels | 2 | 2 |
| RF Type | bipolar | bipolar |
| Max. RF Power | 60 W (2x30 W) | 60 W (2x30 W) |
| RF Frequency | 27.12 Mhz | 27.12 Mhz |
| Number ofMagnetic coils inthe Applicators | 1 | 1 |
| Magnetic FieldIntensity (on thecoil surface) | AP-C-1 - 0.5 to 1.8 TAP-C-2 - 0.7 to 2.0 TAP-C-4/5 - 0.35 to 1.3 T | AP-C-1 - 0.5 to 1.8 TAP-C-2 - 0.7 to 2.0 TAP-C-4/5 - 0.35 to 1.3 T |
| Pulse RepetitionRate - supportedby the device | 1 – 150 Hz | 1 – 150 Hz |
| Pulse Duration | AP-C-1 - 280 μs ± 20% μsAP-C-2 - 190 μs ± 20% μsAP-C-4/5 - 260 μs ± 20% μs | AP-C-1 - 280 μs ± 20% μsAP-C-2 - 190 μs ± 20% μsAP-C-4/5 - 260 μs ± 20% μs |
| Waveform | Biphasic | Biphasic |
| Shape | Sinusoidal | Sinusoidal |
| TemperatureSensor | Yes | Yes |
| Selection ofparameters(Intensity, Time) | Yes | Yes |
| Application | Hands-free, applicator fixed byfixation belt | Hands-free, applicator fixed byfixation belt |
| Therapy Time | Up to 30 min | Up to 30 min |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| SystemDimensions(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) |
| System Weight | 85 kg | 85 kg |
| Operating AmbientTemperature | +10°C to +30°C | +10°C to +30°C |
| Operating RelativeHumidity | 30% to 75% | 30% to 75% |
| EnvironmentalSpecifications | For indoor use only | For indoor use only |
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trics
Substantial Equivalence
The BTL-899F device has expanded indications for use based on positive results from clinical testing.
The predicate device BTL-899A (K213344) and the proposed device have identical mechanisms of action and technology.
The safety of the device has been evaluated and no new risks have been identified.
Therefore these differences do not raise any 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-899F 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.