(140 days)
BTL-499 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-499 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-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The BTL-499 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
Given the provided document, the device in question is the BTL-499, an electrosurgical device. The document states "Clinical Testing: Not applicable to this submission" on page 5. This explicitly indicates that no clinical studies were performed for this submission, and therefore, no data exists to answer questions regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for clinical performance.
The document primarily focuses on non-clinical testing for electrical safety and compliance with medical device standards, and a comparison to predicate devices to demonstrate substantial equivalence based on technological characteristics and intended use, rather than direct comparative clinical performance.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance evaluation, which was explicitly stated as "Not applicable to this submission."
Here's a breakdown of what can be determined from the document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Non-Clinical/Safety Standards): The document lists several IEC and ISO standards that the BTL-499 device was found to comply with. These standards implicitly serve as the acceptance criteria for the non-clinical performance (safety, EMC, software lifecycle, risk management, biocompatibility).
- 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
- Reported Device Performance (against standards): The document states: "The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards." This is the reported performance – that it complies with the listed standards. No specific quantitative performance metrics beyond compliance are provided in this summary.
The following information is NOT available in the provided text because clinical testing was not applicable to this submission:
- 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for this submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. The device is not described as an AI-assisted device in this context, and no clinical comparative effectiveness study against human readers was performed.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an energy delivery system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth data was used for this submission.
- 8. The sample size for the training set: Not applicable. No training set for clinical performance was used.
- 9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 23, 2024
BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752
Re: K233849
Trade/Device Name: Btl-499 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: March 28, 2024 Received: March 28, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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: 2024.04.23 15:50:17 -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
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Indications for Use
Submission Number (if known)
Device Name
BTL-499
Indications for Use (Describe)
BTL-499 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-499 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 tvpes II and BMI 30 and under.
The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
( 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 three overlapping blue squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
510(k) Summary
K######
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: | November 20, 2023 |
| Device | |
| Trade/Proprietary Name: | BTL-499 |
| Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
Classification Product Code: GEI, PBX
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a stylized graphic to the left of the text "BTL Industries". The graphic is made up of three interlocking squares, each rotated 45 degrees. The text is in a simple, sans-serif font and is a dark gray color.
Legally Marketed Predicate Device
The BTL-499 is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
BTL-899F Original 510(k) Sponsor: BTL Industries, Inc. 510(k) Number: K230467
BTL-785X BTL-785-1 applicator and BTL-785-1-4 attachment Original 510(k) Sponsor: BTL Industries Inc. 510(k) Number: K222556
Product Description
The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-499 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Technological characteristics
The BTL-499 device has similar technological characteristics compared to its predicate devices. The BTL-499 device and the predicates are comprised of a system console and applicators.
The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
Indications for Use
BTL-499 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-499 is intended for use with skin types I - VI.
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-
BTL Industries
-
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-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing (Performance, Bench Testing)
The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety andessential 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 |
| 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 |
Clinical Testing
Not applicable to this submission
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares arranged in a triangular pattern on the left, with the letters "BTL" inside the squares. To the right of the squares, the words "BTL Industries" are written in a simple, sans-serif font. The logo is clean and modern, with a focus on geometric shapes and clear typography.
Comparison with the Predicate Device
| 510(k) number | Not assigned | K230467 | K222556 |
|---|---|---|---|
| Device name | BTL-499 | BTL-899F | BTL-785X withBTL-785-1 & BTL-785-1-4 |
| Companyname | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Codeand Regulation | General & PlasticSurgery21 CFR 878.4400GEI - Electrosurgical,Cutting & Coagulation& AccessoriesPBX - Massager,Vacuum,RadiofrequencyInduced Heat | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical,Cutting & Coagulation &Accessories | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & AccessoriesPBX - Massager, Vacuum,Radiofrequency Induced Heat |
| Indications forUse | BTL-499 is indicated tobe used for:Non-invasivelipolysis(breakdown of fat)of the abdomen. Reduction incircumference ofthe abdomen. Non-invasivelipolysis(breakdown of fat)of the thighs. Reduction incircumference ofthe thighs. BTL-499 isintended for usewith skin typesI – VI. Non-invasivelipolysis(breakdown of fat)of the flankslimited to skintypes I - IV. Non-invasive | BTL-899F is indicated to beused for:Non-invasivelipolysis(breakdown of fat)of the abdomen. Reduction incircumference ofthe abdomen. Non-invasivelipolysis(breakdown of fat)of the thighs. Reduction incircumference ofthe thighs. BTL-899F isintended for usewith skin typesI – VI. Non-invasivelipolysis(breakdown of fat)of the flankslimited to skintypes I - IV. Non-invasive | The BTL-785X device has thefollowing indications for use:The BTL-785X with BTL-785-1applicator is intended to provideheating for the purpose ofelevating tissue temperature forselected medical conditionssuch as temporary relief of pain,muscle spasms, and increase inlocal circulation.The BTL-785-1-4 massagedevice is intended to providea temporary reduction in theappearance of cellulite. |
| (breakdown of fat)of the upper armslimited to skin typesII and III andBMI 30 and under.The BTL-499 is intendedto provide heating for thepurpose of elevatingtissue temperature forselected medicalconditions such astemporary relief of pain,muscle spasms, andincrease in localcirculation.The BTL-499 massagefunction is intended toprovide a temporaryreduction in theappearance of cellulite. | (breakdown of fat)of the upper armslimited to skin typesII and III andBMI 30 and under | ||
| ElectricalProtection | Class II, BF | Class II, BF | Class II, BF |
| Clinical Use | Prescription use | Prescription use | Prescription use |
| Interface | Touch screen | Touch screen | Touch screen |
| Type of Energy | The system combinesbipolar radiofrequencywith electromagneticstimulation andmechanical massage. | The system combinesbipolar radiofrequency withelectromagnetic stimulation. | The system combinesradiofrequency with mechanicalmassaging of body parts withmassage attachment. |
| Source ofelectro-magneticstimulation | Single magnetic coil | Single magnetic coil | N/A |
| Number ofoutputchannels | 2 | 2 | N/A |
| Color TouchScreen | 15.6 in39.6 cm1920x1080 pixels | 15.6 in39.6 cm1920x1080 pixels | 15.6 in39.6 cm1920x1080 pixels |
| Type ofOperation | Continuous | Continuous | Continuous |
| PulseRepetitionRate -supported bythe device | 1 – 150 Hz | 1 – 150 Hz | N/A |
| Magnetic FieldIntensity | 499-AP-MRA-1 -0.5 to 1.8 T499-AP-MR-2 - 0.7 to 2.0 T499-AP-MRA-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 | N/A |
| Pulse Duration | 499-AP-MRA-1 -255 µs ± 20%499-AP-MR-2 -190 µs ± 20%499-AP-MRA-4/5 -245 µs ± 20% | AP-C-1 -280 µs ± 20AP-C-2 -190 µs ± 20%AP-C-4/5 -260 µs ± 20% | N/A |
| PulseAmplitude | 0—100 % | 0—100 % | N/A |
| Shape ofStimulationPulse | Sine, biphasic | Sine, biphasic | Sine, biphasic |
| Type of Pulse | bipolar | bipolar | Monopolar |
| Max. RF Power | 60W (2x30 W) | 60W (2x30 W) | 140W |
| RF Frequency | 27.12 Mhz | 27.12 Mhz | 3.2 MHz |
| TemperatureSensor | Yes | Yes | Integrated thermometer +patient's feedback |
| Selection ofparameters(Intensity,Time) | Yes | Yes | Yes |
| Types ofapplicators | 3 | 3 | 1 |
| Therapy Time | Up to 30 min | Up to 30 min | Up to 30 min |
| Application | Hands-free, applicatorfixed by fixation belt | Hands-free, applicator fixedby fixation belt | Manual application of thetherapy and massage |
| Massagefrequency | 0 — 40Hz | N/A | Manual application via attachedmassage device |
| Massageintensity | 0 - 100% | N/A | Manual application via attachedmassage device |
| Energy Source | 100 - 240 V AC,50—60 Hz | 100 - 240 V AC,50—60 Hz | 100-120 V AC /200-240 V AC, 50/60 Hz |
| SystemDimensions | 23 x 52 x 35 in(593 x 1313 x 894 mm) | 23 x 39 x 29 in(592 x 985 x 730 mm) | 26 x 26 x 54 in(670 x 670 x 1370 mm) |
| System Weight | 76 kg | 85 kg | 65 kg |
| OperatingAmbientTemperature | +10°C to +30°C | +10°C to +30°C | +18 °C to +30 °C |
| OperatingRelativeHumidity | 30% to 75% | 30% to 75% | 30% to 75% |
| EnvironmentalSpecifications | For indoor use onlyIn vertical position – | For indoor use onlyIn vertical position – On | For indoor use onlyIn vertical position - On castors |
510(k) Summary Page 4 of 8
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Image /page/7/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 overlapping squares, each with the letters "BTL" inside.
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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, each containing the letters "BTL". The squares are arranged in a staggered formation, with the first square slightly higher than the second, and the second square slightly higher than the third. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
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Image /page/9/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 colors are clean and professional.
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Image /page/10/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, with the letters "BTL" inside the leftmost square. The text "BTL Industries" is written in a sans-serif font and is also blue.
Substantial Equivalence
The BTL-499 device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL-499 device. Any differences between the predicate devices and BTL-499 have no significant influence on safety and effectiveness of the BTL-499 device. Therefore, the BTL-499 is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-499 device has been shown to be substantially equivalent to currently marketed predicate devices.
§ 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.