(323 days)
No
The summary describes a device that delivers electromagnetic and radiofrequency energy with user-settable parameters and on-screen guidance, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device description explicitly states, "The BTL-703-2 is a non-invasive therapeutic device."
No
The BTL-703-2 is described as a "non-invasive therapeutic device" intended for muscle strengthening, toning, and firming, which are therapeutic rather than diagnostic functions. Its intended use and device description do not mention any capability to identify, measure, or monitor a medical condition or disease.
No
The device description explicitly states it is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency, indicating it includes hardware components beyond just software.
Based on the provided information, the BTL-703-2 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device used for improving muscle tone and firmness in various body parts. This is a direct treatment applied to the patient's body.
- Device Description: The description details a non-invasive therapeutic device that delivers electromagnetic and radiofrequency energy to targeted tissue. This is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BTL-703-2 does not fit this description.
N/A
Intended Use / Indications for Use
BTL-703-2 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, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The BTL-703-2 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 keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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)
The BTL-703-2 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 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 lifecycle 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
January 6, 2021
BTL David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K200382
Trade/Device Name: BTL-703-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 10, 2020 Received: December 14, 2020
Dear David Chmel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200382
Device Name BTL-703-2
Indications for Use (Describe) BTL-703-2 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, 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) | □ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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 leftmost 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 use of blue and gray gives it a professional look.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | 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: | 31 December 2020 |
Device Name
| Trade/Proprietary Name: | BTL-703-2 |
|---|---|
| Primary Classification Name: | Stimulator, Muscle, Powered, Muscle Conditioning |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |
4
Image /page/4/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 leftmost square. To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font. The text is aligned horizontally with the logo.
Legally Marketed Predicate Device
The BTL-703-2 is a state-of-the-art device with accessories combining electromagnetic and high frequency energy, and is substantially equivalent to the following product, which is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- 799-2L (K190456) ●
Reference Device BTL-899
The reference device has been added to this section because it is technologically similar to the BTL-703-2 device. Both devices are tracked internally under a common project number, P899. Hence, all test reports and technical documentation refer to this number.
Product Description
The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-703-2 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 keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Indications for Use
BTL-703-2 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, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms. ●
5
Non-clinical Testing
The BTL-703-2 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 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 lifecycle 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 |
Technological Characteristics
The BTL-703-2 device has similar indications for use and technological characteristics and principles of operation to its predicate device. The BTL-703-2 device and its predicate are comprised of a system console and applicators. The system console consists of the electromagnetic field and radiofrequency generators, computer, and a touch-screen control panel.
The generated electromagnetic field is intenact with the tissues of the human body in order to achieve muscle stimulation. The radiofrequency is providing a low degree of warming of the applicators and thus enhance the patient's comfort during the treatment.
The mechanism of action and technological similarities and differences between the BTL-703-2 device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
6
Comparison with the Predicate Devices
| 510(k)
number
Device name
Company
name | K200382
BTL-703-2
BTL Industries, Inc. | K190456
BTL 799-2L
BTL Industries, Inc. | Reference Device
K192224
BTL-899
BTL Industries, Inc. | Significant
difference |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 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 | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical,
Cutting & Coagulation &
Accessories | None |
| Indications
for Use | BTL-703-2 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, thighs
and calves.Improvement of
muscle tone and
firmness, for
strengthening
muscles in arms. | 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. | BTL-899 is indicated to
be used for:
Non-invasive
lipolysis (breakdown
of fat) of the
abdomen.Reduction in
circumference of
the abdomenThe BTL-899 is intended
for use with Skin Type I to
Skin Type III. | Not
Significantly
different |
| Basic
Technology | Electromagnetic
stimulation
accompanied by
bipolar radiofrequency | Electromagnetic
stimulation | Electromagnetic
stimulation
accompanied by
bipolar radiofrequency | Not
Significantly
different
Please see the
discussion and |
7
Image /page/7/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side of the image. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
| | | | | conclusion
below |
|---------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Clinical Use | Prescription use | Prescription use | Prescription use | None |
| Electrical
Protection | Class II, BF | Class II, BF | Class II, BF | None |
| User
Interface | Touch screen | Touch screen | Touch screen | None |
| Firmware
Controlled | Yes | Yes | Yes | None |
| Number of
outputs
channels | 2 | 2 | 2 | Not
Significantly
different |
| Number of
output
modes* | 1 | 1 | 1 | None |
| Number of
Magnetic
coils
in the
Applicator | 1 | 1 | 1 | None |
| Magnetic
Field
Intensity (on
the coil
surface) | 0.5 to 1.8 T
for app:
BTL-899-AP-C-1 | 0.5 to 1.8 T
for app:
BTL 299-6 | 0.5 to 1.8 T
for app:
BTL-899-AP-C-1 | None |
| Magnetic
Field
Intensity (on
the coil
surface) | 0.7 to 2.0 T
for app:
BTL-899-AP-C-2 | 0.7 to 2.0 T
for app:
BTL 299-7 | N/A | None |
| Maximum
magnetic | 908 mT | 980 mT | 908 mT | None |
| field
intensity at
applicator
center
surface | for app: BTL-899-AP-
C-1 | for app:
BTL 299-6 | for app: BTL-899-AP-
C-1 | None |
| Maximum
magnetic
field
intensity at
applicator
center
surface | 1238 mT
for app: BTL-899-AP-
C-2 | 1220 mT
for app:
BTL 299-7 | 1238 mT | None |
| Pulse
Repetition
Rate -
supported
by the
device | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz | None |
| Pulse
Duration | $280 \mu s \pm 20% \mu s$
for app:
BTL-899-AP-C-1 | $280 \mu s \pm 20% \mu s$
for app:
BTL 299-6 | $280 \mu s \pm 20% \mu s$
for app:
BTL-899-AP-C-1 | None |
| Pulse
Duration | $190 \mu s \pm 20% \mu s$
for app:
BTL-899-AP-C-2 | $190 \mu s \pm 20% \mu s$
for app:
BTL 299-7 | N/A | None |
| Waveform | Biphasic | Biphasic | Biphasic | None |
| Shape | Sinusoidal | Sinusoidal | Sinusoidal | None |
| RF Type | Bipolar | N/A | Bipolar | Not
Significantly
different
Please see
discussion on
basic technology
below |
| Total RF
Power | 60 W (2x30) | N/A | 60 W (2x30) | Not
Significantly
different
Please see
discussion on
basic technology
below |
| RF
Frequency | 27.12 Mhz | N/A | 27.12 Mhz | Not
Significantly
different
Please see
discussion on
basic technology
below |
| Overheating
Protection
Sensor | Yes | N/A | Yes | Not
Significantly
different |
| Selection of
parameters | Yes | Yes | Yes | None |
| Application | Hands-free, applicator
fixed by fixation belt | Hands-free,
applicator fixed by
fixation belt | Hands-free, applicator
fixed by fixation belt | Not
Significantly
different |
| Therapy
Time | Up to 30 min | Up to 60 min | Up to 30 min | Not
Significantly
different |
| Energy
Source | 100 - 240 V AC, 50-
60 Hz | 100 - 240 V AC, 50-
60 Hz | 100 - 240 V AC, 50-
60 Hz | None |
| Maximum
Output
Voltage | N/A | N/A | N/A | N/A |
| Maximum
Output
Current | N/A | N/A | N/A | N/A |
| Maximum
Current
Density
(mA/cm²) | N/A | N/A | N/A | N/A |
| Maximum
Phase
Charge,
(mC) | N/A | N/A | N/A | N/A |
| Maximum
Power
Density*
(W/cm²) | N/A | N/A | N/A | N/A |
| System
Dimensions
(W×H×D) | 23 x 39 x 29 in
(592 x 985 x 730 mm) | 23 x 55 x 23 in
(580x1380x580 mm) | 23 x 39 x 29 in
(592 x 985 x 730 mm) | Not
Significantly
different |
| System
Weight | 85 kg | 44 kg | 85 kg | Not
Significantly
different |
| Ambient
Storage
Temperature | 14 °F to 131 °F (-10°C
to +55°C) | 14 °F to 131 °F (-
10°C to +55°C) | 14 °F to 131 °F (-10°C
to +55°C) | None |
| Relative
Storage
Humidity | 10% to 85% | 10% to 85% | 10% to 85% | None |
| Environment
al
Specificatio
ns | For indoor use only | For indoor use only | For indoor use only | None |
8
Image /page/8/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a dark gray sans-serif font.
9
Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside each other. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
10
Image /page/10/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 logo is the text "BTL Industries" in a sans-serif font.
Substantial Equivalence
The BTL-703-2 is indicated for improvement of abdominal tone, strengthening of the abdominal muscles and development of firmer abdomen, as well as for strengthening, toning and firming of buttocks, thighs and calves. These indications are the same as the predicate device's indications.
The predicate device BTL-799L utilizes electromagnetic stimulation in order to achieve therapeutic effect. The proposed device BTL-703-2 also utilizes electromagnetic stimulation for its main therapeutic effect; however, the device is also equipped with a bipolar radiofrequency generator. The radiofrequency is warming the applicators' surface to below 40℃ thus enhancing the patient's comfort during the treatment.
The BTL-703-2 electromagnetic technology is identical to FDA cleared predicate device BTL 799-2L. The bipolar radiofrequency technology has also been cleared by FDA in a number of devices, for example BTL-899 (K192224).
11
Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font.
Any differences between the predicate device and BTL-703-2 have no significant influence on the safety or effectiveness of the BTL-703-2 device. Therefore, the BTL-703-2 is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-703-2 device has been shown to be substantially equivalent to the currently marketed predicate devices.