(130 days)
Not Found
No
The summary describes a non-invasive therapeutic device that uses electromagnetic fields and a touch screen interface for setting parameters. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, decision-making, or personalized treatment. The focus is on the physical mechanism of action and user interface.
Yes
Reason: The device description explicitly states, "The BTL 799-2L is a non-invasive therapeutic device." Additionally, its intended use for improvement of muscle tone and strengthening aligns with therapeutic purposes.
No
The Intended Use / Indications for Use section clearly states the device is for "Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen," and "Strengthening, Toning and Firming of buttocks, thighs and calves," and "Improvement of muscle tone and firmness, for strengthening muscles in arms." These are all therapeutic actions, not diagnostic ones. The Device Description also calls it a "non-invasive therapeutic device."
No
The device description explicitly states it is a "non-invasive therapeutic device" that "produces electromagnetic field" and has "two outputs that enable simultaneous treatment by two applicators." It also mentions a "large color touch screen" and setting "therapeutic parameters." These are all hardware components and functionalities, indicating it is not a software-only device.
Based on the provided information, the BTL 799-2L is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for improving muscle tone, strengthening muscles, and firming various body parts. This is a therapeutic application, not a diagnostic one.
- Device Description: The description states the device produces an electromagnetic field that interacts with the tissues of the human body. This is a physical interaction with the body, not the examination of specimens taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BTL 799-2L's function is entirely focused on directly affecting the body's muscles for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for Use
BTL 799-2L is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
Product codes
NGX
Device Description
The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has two outputs that enable simultaneous treatment by two applicators.
The BTL 799-2L is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The BTL 799-2L device and its predicates are comprised of a system console and applicator(s). The system console consists of the electromagnetic field generators, computer, and the touch-screen control panel.
Generated electromagnetic field is intended to interact with the tissues of the human body to achieve muscle stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, buttocks, thighs, calves, arms
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)
Non-clinical Testing
The BTL 799-2L 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 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-10 Medical Electrical Equipment – Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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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 side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 5, 2019
BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K190456
Trade/Device Name: BTL 799-2L Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 4, 2019 Received: April 9, 2019
Dear David Chmel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek Pinto, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190456
Device Name BTL 799-2L
Indications for Use (Describe)
BTL 799-2L is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
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 blue squares that are interlocked with each other. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
510(k) Summary
K190456
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
Date: | June 28, 2019 |
Device Name
| Trade/Proprietary Name: | BTL 799-2L |
|---|---|
| Primary Classification Name: | Stimulator, Muscle, Powered |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |
Legally Marketed Predicate Device
The BTL 799-2L is a state-of-the-art electromagnetic device with accessories, and is substantially equivalent to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- . primary predicate 799-2T (K182106)
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each nested inside the other, with the letters "BTL" in white inside the innermost square. To the right of the squares 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.
- secondary predicate HPM-6000 (K160992) ●
Product Description
The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has two outputs that enable simultaneous treatment by two applicators.
The BTL 799-2L is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Intended Use
BTL 799-2L is indicated to be used for:
- . Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- . Improvement of muscle tone and firmness, for strengthening muscles in arms.
Non-clinical Testing
The BTL 799-2L 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 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-10 | Medical Electrical Equipment – Part 2-10: Particular Requirements for
the Basic Safety and Essential Performance of Nerve and Muscle
Stimulators |
| IEC 62304 | Medical device software - Software life cycle processes |
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares on the left, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a sans-serif font. The squares are a dark blue color, while the text is a dark gray color.
| 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 |
Technological Characteristics
The BTL 799-2L device has similar indications for use, technological characteristics and principles of operation to its predicate devices. The BTL 799-2L device and its predicates are comprised of a system console and applicator(s). The system console consists of the electromagnetic field generators, computer, and the touch-screen control panel.
Generated electromagnetic field is intended to interact with the tissues of the human body to achieve muscle stimulation.
The technological similarities and differences between the BTL 799-2L device and predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
| 510(k) number | K190456 | K182106 | K160992 |
|---|---|---|---|
| Device name | BTL 799-2L | BTL 799-2T | HPM-6000 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code | |||
| and Regulation | Physical Medicine | ||
| 21 CFR 890.5850 | |||
| NGX - Stimulator, Muscle, | |||
| Powered, Muscle Conditioning | Physical Medicine | ||
| 21 CFR 890.5850 | |||
| NGX - Stimulator, Muscle, | |||
| Powered, Muscle Conditioning | Physical Medicine | ||
| 21 CFR 890.5850 | |||
| IPF - Stimulator, Muscle, | |||
| Powered | |||
| Intended Use | BTL 799-2L is indicated to be | ||
| used for: | |||
| • Improvement of abdominal | |||
| tone, strengthening of the | |||
| abdominal muscles, | |||
| development of firmer | |||
| abdomen. | |||
| • Strengthening, Toning and | BTL 799-2T is indicated to be | ||
| used for: | |||
| • Improvement of abdominal | |||
| tone, strengthening of the | |||
| abdominal muscles, | |||
| development of firmer | |||
| abdomen. | |||
| • Strengthening, Toning and | Indications for Use for Muscle | ||
| Stimulators: | |||
| • Relaxation of muscle spasms | |||
| • Prevention or retardation of | |||
| disuse atrophy | |||
| • Increasing local blood | |||
| circulation | |||
| • Muscle re-education | |||
| 510(k) number | K190456 | K182106 | K160992 |
| Device name | BTL 799-2L | BTL 799-2T | HPM-6000 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. |
| Firming of buttocks, thighs | |||
| and calves. | |||
| • Improvement of muscle tone | |||
| and firmness, for | |||
| strengthening muscles in | |||
| arms. | Firming of buttocks and | ||
| thighs. | |||
| • Improvement of muscle tone | |||
| and firmness, for | |||
| strengthening muscles in | |||
| arms. | • Immediate post-surgical | ||
| stimulation of calf muscles to | |||
| prevent venous thrombosis | |||
| • Maintaining or increasing | |||
| range of motion | |||
| Principle of Action | Initiating action potential of | ||
| nerves results in muscle | |||
| contraction | Initiating action potential of | ||
| nerves results in muscle | |||
| contraction | Initiating action potential of | ||
| nerves results in muscle | |||
| contraction | |||
| Clinical Use | Prescription use | Prescription use | Prescription use |
| Electrical | |||
| Protection | Class II, BF | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen | Touch screen |
| Firmware | |||
| Controlled | Yes | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field |
| Number of outputs | 2 | 2 | 1 |
| Number of | |||
| Magnetic Coils | |||
| in the Applicator | 1 | 1 | 1 |
| Magnetic Field | |||
| Intensity | BTL 299-6 applicator: 0.5 - 1.8 T | ||
| ±20% | BTL 299-6 applicator: 0.5 - 1.8 T | ||
| ±20% | BTL 299-1 applicator: 0.5 - 1.8 T | ||
| ±20% | |||
| BTL 299-7 applicator: 0.7 - 2.0 T | |||
| ±20% | N/A | BTL 299-2 applicator: 0.7 - 2.5 T | |
| ±20% | |||
| Maximum | |||
| Magnetic Field | BTL 299-6 applicator: 1.154 T | ||
| ±20% | BTL 299-6 applicator: 1.154 T | ||
| ±20% | BTL 299-1 applicator: 1.220 T | ||
| ±20% | |||
| Intensity at | |||
| Applicator Center | |||
| Surface | BTL 299-7 applicator: 1.173 T | ||
| ±20% | N/A | BTL 299-2 applicator: 1.412 T | |
| ±20% | |||
| Pulse Repetition | |||
| Rate | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz |
| 510(k) number | K190456 | K182106 | K160992 |
| Device name | BTL 799-2L | BTL 799-2T | HPM-6000 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. |
| Pulse Duration | BTL 299-6 applicator: 280 ± | ||
| 20% μs | BTL 299-6 applicator: 280 ± | ||
| 20% μs | BTL 299-1 applicator: 280 ± | ||
| 20% μs | |||
| BTL 299-7 applicator: 190 ± | |||
| 20% μs | N/A | BTL 299-2 applicator: 280 ± | |
| 20% μs | |||
| Selection of | |||
| parameters | |||
| (Intensity, Time) | Yes | Yes | Yes |
| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| System | |||
| Dimensions | |||
| (W×H×D) | 580×1380×580 mm | ||
| (23×55×23 in) | 580×1380×580 mm | ||
| (23×55×23 in) | 500×970×580 mm | ||
| (20×38×23 in) | |||
| Ambient | |||
| Temperature | -10°C to +55°C | -10°C to +55°C | -10°C to +55°C |
| Relative Humidity | 10% to 85% | 10% to 85% | 10% to 85% |
| Environmental | |||
| Specifications | For indoor use only | For indoor use only | For indoor use only |
Comparison with the Predicate Device
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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 that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industrie. 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 Industrie" in gray.
Substantial Equivalence
The BTL 799-2L device is intended for improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; strengthening, toning and firming of buttocks and thighs; improvement of muscle tone and firmness, for strengthening muscles in arms, identically compared to the primary predicate device. Additionally, the BTL 799-2L device is intended for calves strengthening, toning and firming, which is supported by the secondary predicate device HPM-6000.
The BTL 799-2L, when compared to the primary predicate device, may be used with two types of applicators. Applicator BTL 299-6 is identical to the applicator of the primary predicate device. The new applicator BTL 299-7 is of smaller size on the ground that it is intended to be used for smaller treatment areas, such as calves.
The BTL 299-7 applicator has slightly higher magnetic field intensity and shorter pulse width when compared to the applicator of the primary predicate device. However, magnetic field
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares, with the letters "BTL" inside the innermost square. To the right of the square logo is the text "BTL Industries" in a simple sans-serif font. The logo is in blue, while the text is in gray.
intensity is within the range of the BTL 299-2 applicator of the second predicate device. Pulse duration is shorter due to the smaller coil surface intended for smaller muscle parts.
The applicator of the primary predicate device (BTL 299-6) has wider field exposure compared to the currently submitted BTL 299-7 applicator. This is because the BTL 299-7 coil is smaller than the one in the BTL 299-6 applicator, due to the fact that the BTL 299-6 applicator is intended for larger groups of muscles, while the new BTL 299-7 applicator is intended for smaller muscle parts, particularly arms and calves.
All named applicators are based on identical principle, mechanism of action, as well as manufacturing material. The system console, consisting of the electromagnetic field generators, computer, and the touch-screen control panel is also identical to the predicate devices.
Any differences between the predicate devices and BTL 799-2L device have no significant influence on safety or effectiveness of the BTL 799-2L device. Therefore, the BTL 799-2L device 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 799-2L device has been shown to be substantially equivalent to currently marketed predicate devices.