· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.

Device Description

The BTL 799-2 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the BTL 799-2 helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The BTL 799-2 is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information quides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called BTL 799-2, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (AM-100) rather than presenting a clinical study with detailed acceptance criteria and performance metrics for the BTL 799-2 itself.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of clinical performance (e.g., accuracy, sensitivity, specificity).

Instead, the document details non-clinical testing to ensure safety and compliance with medical device standards. The "acceptance criteria" in this context are compliance with these standards, not clinical performance metrics.

Here's a breakdown of why the requested information cannot be fully provided from this document:

Table of acceptance criteria and reported device performance: This document does not establish clinical performance acceptance criteria (e.g., specific percentages for improvement in abdominal tone) or report device performance against such criteria. Its entire purpose is to show technological and intended use equivalency to a previously cleared device.
- Acceptance Criteria (as implied by the document for regulatory clearance): Compliance with relevant electrical safety and biocompatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Reported Device Performance: The document states the BTL 799-2 "has been found to comply" with these standards. No specific performance metrics (e.g., current output, magnetic field intensity) are presented as "reported device performance" against explicit "acceptance criteria" related to a clinical outcome. The technical specifications (Magnetic Field Intensity, Pulse Repetition Rate, Pulse Duration, Induced Current in the Tissue) are listed as characteristics, but not as performance against a target.
Sample size used for the test set and data provenance: Not applicable. No clinical test set data is presented. The "test set" for this submission was the device itself, tested against engineering and safety standards.
Number of experts used to establish the ground truth and their qualifications: Not applicable. No clinical ground truth was established from patient data.
Adjudication method for the test set: Not applicable. No clinical test set required adjudication.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance, usually with imaging or diagnostic devices. The BTL 799-2 is a therapeutic muscle stimulator.
Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a therapeutic device, not an AI or diagnostic algorithm.
Type of ground truth used: Not applicable for clinical performance. For safety and substantial equivalence, the "ground truth" refers to recognized medical device standards and the characteristics of the predicate device.
Sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires training data.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The BTL 799-2 device's "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to an already cleared predicate device (AM-100) and compliance with relevant electrical safety and biocompatibility standards.

Acceptance Criteria (Implicit for Substantial Equivalence and Safety):

Same Intended Use: The device must have the same indications for use as the predicate (improvement of abdominal tone, strengthening of abdominal muscles, firmer abdomen; strengthening, toning, and firming of buttocks and thighs).
Similar Technological Characteristics: The device must operate on similar principles (magnetic field, muscle stimulation) and have comparable technical specifications, or any differences must not raise new safety or effectiveness concerns.
Compliance with Safety Standards: The device must pass non-clinical testing against a suite of recognized international safety and biocompatibility standards.

Study/Evidence that Proves Meeting Acceptance Criteria:

The "study" in this context is the 510(k) submission itself, which provides a comparative analysis of the BTL 799-2 with the predicate device (AM-100) and documentation of non-clinical testing results.

Acceptance Criterion	Reported Device Performance/Evidence from Document
Intended Use Equivalence	- BTL 799-2 Indications: "Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs." - AM-100 Indications: "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs." - Conclusion: "The BTL 799-2 device has the same intended use as its predicate devices."
Technological Equivalence & Safety	- Principle of Action: Both BTL 799-2 and AM-100 state "Initiating action potential of nerves results in muscle contraction."- Type of Energy: Both utilize "Magnetic field."- Pulse Repetition Rate: Both 1 - 150 Hz.- Pulse Duration: Both 280 ± 20% µs.- Induced Current in the Tissue: Both 28-30 mA.- Differences Addressed: BTL 799-2 has a larger touch screen (15.6" vs 8.4") and two outputs (vs one for AM-100). The document states: "The technological differences between the BTL 799-2 device and the predicate device do not raise any new types of safety or effectiveness questions."
Compliance with Safety and EMC Standards	- Standards Listed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10.- Reported Performance: "The BTL 799-2 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards." (No specific test results or failure rates are provided in this summary, just a statement of compliance).
Biocompatibility	- Standards Listed: ISO 10993-1, ISO 10993-5, ISO 10993-10.- Reported Performance: Implicitly "found to comply" as part of the non-clinical testing section.

This document serves as regulatory submission for substantial equivalence based on technical comparisons and adherence to relevant standards, not a clinical trial evaluating specific performance metrics against a predefined acceptance threshold.

Summary

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 14, 2018 BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752

Re: K180813

Trade/Device Name: BTL 799-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: March 26, 2018 Received: March 29, 2018

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. 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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2018.06.14 16:14:26 -04'00'

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K180813

Device Name BTL 799-2

Indications for Use (Describe)

BTL 799-2 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 and thighs.

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)
X

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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares with the letters "BTL" inside each 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.

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:	June 14, 2018

Device Name

Trade/Proprietary Name:	BTL 799-2
Primary Classification Name:	Stimulator, Muscle, Powered
Classification Regulation:	21 CFR 890.5850, Class II
Classification Product Code:	NGX

Legally Marketed Predicate Devices

The BTL 799-2 is a state-of-the-art magnetic 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 number:

. AM-100 (K163165)

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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 containing the letters "BTL" in white. The squares are arranged in a row, with the first square slightly offset to the left and the third square slightly offset to the right. To the right of the squares is the text "BTL Industries" in gray.

Product Description

The BTL 799-2 is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information quides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on 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 799-2 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 and thighs.

Non-clinical Testing

The BTL 799-2 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 62366	Medical devices - Application of usability engineering to medicaldevices
IEC 62304	Medical device software - Software life cycle processes
ISO 14971	Medical devices – Application of risk management to medical devices

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Image /page/5/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" stacked vertically inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

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 799-2 device has the same indications for use and similar technological characteristics and principles of operation as its predicate device. The BTL 799-2 device and its predicate 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 Essential technical characteristics of the BTL 799-2 and its predicate device, particularly the type of energy, pulse characteristics, type of operation and therapy time, are identical.

Compared to the predicate, the BTL 799-2 device is equipped with larger touch-screen control panel to increase user comfort. Technical characteristics of the applicator are comparable to its predicate. The subject device has two outputs to enable simultaneous treatment by two applicators.

The technological differences between the BTL 799-2 device and the predicate device do not raise any new types of safety or effectiveness questions.

510(k) number	Not Assigned	K163165
Device name	BTL 799-2	AM-100
Company name	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

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 interconnected blue squares with the letters "BTL" inside each square. To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font.

510(k) number	Not Assigned	K163165
Device name	BTL 799-2	AM-100
Company name	BTL Industries, Inc.	BTL Industries, Inc.
Intended Use	BTL 799-2 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 and thighs.	AM 100 is indicated to be used for:• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.• Strengthening, Toning and Firming of buttocks and thighs.
Primary Function	Muscle stimulation	Muscle stimulation
Principle of Action	Initiating action potential of nerves results in muscle contraction	Initiating action potential of nerves results in muscle contraction
Clinical Use	Prescription use	Prescription use
Electrical Protection	Class II, BF	Class II, BF
User Interface	Touch screen	Touch screen
Touch screen size	15.6" (39.6 cm)	8.4" (21.5 cm)
Firmware Controlled	Yes	Yes
Type of Energy	Magnetic field	Magnetic field
Number of outputs	2	1
Number of MagneticCoilsin the Applicator	1	1
Magnetic FieldIntensity	299-6 applicator: 0.5–1.8 T	299-1 applicator: 0.5–1.8 T299-2 applicator: 0.7–2.5 T
510(k) number	Not Assigned	K163165
Device name	BTL 799-2	AM-100
Company name	BTL Industries, Inc.	BTL Industries, Inc.
Type of Operation	Continuous	Continuous
Pulse Repetition Rate	1 - 150 Hz	1 - 150 Hz
Pulse Duration	280 ± 20% µs	280 ± 20% µs
Pulse Amplitude	0 – 100%	0 – 100%
Induced Current inthe Tissue	28-30 mA	28-30 mA
Selection ofparameters (Intensity,Time)	Yes	Yes
Therapy Time	Up to 60 min	Up to 60 min
Shape of StimulationPulse	Symmetrical Biphasic Sine Wave	Symmetrical Biphasic Sine Wave
Energy Source	100 - 240 V AC, 50-60 Hz	100 - 240 V AC, 50-60 Hz
System Dimensions(W×H×D)	500×1380×580 mm	500×970×580 mm
	(20×55×23 in)	(20×38×23 in)
Ambient Temperature	-10°C to +55°C	-10°C to +55°C
EnvironmentalSpecifications	For indoor use only	For indoor use only

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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, with the letters "BTL" inside the squares. 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 use of blue and gray gives it a professional look.

Substantial Equivalence

The BTL 799-2 device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL 799-2 device. Any differences between the predicate devices and BTL 799-2 device have no significant influence on safety or effectiveness of the BTL 799-2 device. Therefore, the BTL 799-2 device is substantially equivalent to the predicate devices.

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font.

Conclusion

Based upon the intended use and known technical information provided in this pre-market notification, the BTL 799-2 device has been shown to be substantially equivalent to currently marketed predicate device.

Regulation Number and Section

§ 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).