(130 days)
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.
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.
This is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance metrics like sensitivity, specificity, or AUC, a specific sample size for a test set, expert qualifications, or adjudication methods, is not present here.
Instead, the submission focuses on non-clinical testing to ensure safety and essential performance, and a comparison of technological characteristics to predicate devices to argue for substantial equivalence.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the typical sense (e.g., sensitivity, specificity). The acceptance criteria implicitly are compliance with various medical device safety and performance standards (listed below) and having technological characteristics and intended use similar enough to predicate devices to not raise new safety or effectiveness concerns.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity) are reported as this is a comparison to a predicate device, not a de novo performance study. The device's "performance" is demonstrated by its adherence to safety standards and its functional similarity to legally marketed devices.
2. Sample size used for the test set and the data provenance
- This information is not provided as this submission relies on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not through a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as there is no mention of a test set with expert-established ground truth.
4. Adjudication method for the test set
- This information is not provided as there is no mention of a test set or adjudication.
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
- This information is not provided as this device is a physical muscle stimulator, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided as this device is a physical muscle stimulator, not an algorithm.
7. The type of ground truth used
- Not applicable as no clinical study with a ground truth is described. The "ground truth" for this submission revolves around compliance with recognized medical device safety standards and the established safety and effectiveness of the predicate devices it is compared against.
8. The sample size for the training set
- This information is not provided as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- This information is not provided as this is not an AI/machine learning device requiring a training set.
Non-clinical Testing Summary:
The BTL 799-2L device underwent thorough evaluation for electrical safety and compliance 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
The comparison table provided details the technological characteristics of the BTL 799-2L compared to its primary predicate BTL 799-2T (K182106) and secondary predicate HPM-6000 (K160992). The key argument is that any differences do not raise new types of safety or effectiveness questions, thus demonstrating substantial equivalence.
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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.
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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.
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
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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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510(k) Summary
K190456
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: | 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 basicsafety and essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-10 | Medical Electrical Equipment – Part 2-10: Particular Requirements forthe Basic Safety and Essential Performance of Nerve and MuscleStimulators |
| 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 andtesting within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritationand 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 Codeand Regulation | Physical Medicine21 CFR 890.5850NGX - Stimulator, Muscle,Powered, Muscle Conditioning | Physical Medicine21 CFR 890.5850NGX - Stimulator, Muscle,Powered, Muscle Conditioning | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle,Powered |
| Intended Use | BTL 799-2L is indicated to beused for:• Improvement of abdominaltone, strengthening of theabdominal muscles,development of firmerabdomen.• Strengthening, Toning and | BTL 799-2T is indicated to beused for:• Improvement of abdominaltone, strengthening of theabdominal muscles,development of firmerabdomen.• Strengthening, Toning and | Indications for Use for MuscleStimulators:• Relaxation of muscle spasms• Prevention or retardation ofdisuse atrophy• Increasing local bloodcirculation• 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, thighsand calves.• Improvement of muscle toneand firmness, forstrengthening muscles inarms. | Firming of buttocks andthighs.• Improvement of muscle toneand firmness, forstrengthening muscles inarms. | • Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis• Maintaining or increasingrange of motion | |
| Principle of Action | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction |
| Clinical Use | Prescription use | Prescription use | Prescription use |
| ElectricalProtection | Class II, BF | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen | Touch screen |
| FirmwareControlled | Yes | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field |
| Number of outputs | 2 | 2 | 1 |
| Number ofMagnetic Coilsin the Applicator | 1 | 1 | 1 |
| Magnetic FieldIntensity | 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% | |
| MaximumMagnetic 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 atApplicator CenterSurface | BTL 299-7 applicator: 1.173 T±20% | N/A | BTL 299-2 applicator: 1.412 T±20% |
| Pulse RepetitionRate | 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 ofparameters(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 |
| SystemDimensions(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) |
| AmbientTemperature | -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% |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only |
Comparison with the Predicate Device
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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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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.
§ 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).