(140 days)
Not Found
No
The summary describes a device that uses radiofrequency, electromagnetic stimulation, and mechanical massage. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device description explicitly states, "The BTL-499 is a non-invasive therapeutic device." Additionally, its intended uses include temporary relief of pain, muscle spasms, and increased local circulation, which are therapeutic benefits.
No
The device is described as a "non-invasive therapeutic device" for lipolysis, reduction in circumference, temporary pain relief, muscle spasms, increased circulation, and temporary reduction in cellulite appearance. These are all therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is comprised of a "main unit and applicators that deliver energy to the targeted tissue," and includes components like "RF, HV and massage generators," indicating it is a hardware device with software control.
Based on the provided information, the BTL-499 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- BTL-499 Function: The description clearly states that the BTL-499 is a non-invasive therapeutic device. It delivers energy to the targeted tissue externally for purposes like lipolysis, circumference reduction, pain relief, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is based on applying energy and massage to the body's surface.
Therefore, the BTL-499 falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BTL-499 is indicated to be used for:
Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen.
Non-invasive lipolysis (breakdown of fat) of the thighs.
Reduction in circumference of the thighs.
BTL-499 is intended for use with skin types I - VI.
Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV.
Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin tvpes II and BMI 30 and under.
The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
GEI, PBX
Device Description
The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-499 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, Thighs, Flanks, Upper 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 (Performance, Bench Testing)
The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 62304 Medical device software - Software life cycle processes
ISO 14971 Medical devices – Application of risk management to medical devices
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Clinical Testing
Not applicable to this submission
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.
Not Found
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 23, 2024
BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752
Re: K233849
Trade/Device Name: Btl-499 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: March 28, 2024 Received: March 28, 2024
Dear David Chmel:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.23 15:50:17 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
BTL-499
Indications for Use (Describe)
BTL-499 is indicated to be used for:
Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen.
Non-invasive lipolysis (breakdown of fat) of the thighs.
Reduction in circumference of the thighs.
BTL-499 is intended for use with skin types I - VI.
Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV.
Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin tvpes II and BMI 30 and under.
The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping blue squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
510(k) Summary
K######
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm 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: | November 20, 2023 |
| Device | |
| Trade/Proprietary Name: | BTL-499 |
| Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
Classification Product Code: GEI, PBX
4
Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a stylized graphic to the left of the text "BTL Industries". The graphic is made up of three interlocking squares, each rotated 45 degrees. The text is in a simple, sans-serif font and is a dark gray color.
Legally Marketed Predicate Device
The BTL-499 is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
BTL-899F Original 510(k) Sponsor: BTL Industries, Inc. 510(k) Number: K230467
BTL-785X BTL-785-1 applicator and BTL-785-1-4 attachment Original 510(k) Sponsor: BTL Industries Inc. 510(k) Number: K222556
Product Description
The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-499 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Technological characteristics
The BTL-499 device has similar technological characteristics compared to its predicate devices. The BTL-499 device and the predicates are comprised of a system console and applicators.
The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
Indications for Use
BTL-499 is indicated to be used for:
- Non-invasive lipolysis (breakdown of fat) of the abdomen. ●
- Reduction in circumference of the abdomen.
- Non-invasive lipolysis (breakdown of fat) of the thighs.
- Reduction in circumference of the thighs.
- . BTL-499 is intended for use with skin types I - VI.
5
-
BTL Industries
-
Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV. ●
-
Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and . BMI 30 and under.
The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
Non-clinical Testing (Performance, Bench Testing)
The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances
- Requirements and tests |
| IEC 62304 | Medical device software - Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin
sensitization |
Clinical Testing
Not applicable to this submission
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares arranged in a triangular pattern on the left, with the letters "BTL" inside the squares. To the right of the squares, the words "BTL Industries" are written in a simple, sans-serif font. The logo is clean and modern, with a focus on geometric shapes and clear typography.
Comparison with the Predicate Device
| 510(k) number | Not assigned | K230467 | K222556 |
|---|---|---|---|
| Device name | BTL-499 | BTL-899F | BTL-785X with |
| BTL-785-1 & BTL-785-1-4 | |||
| Company | |||
| name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code | |||
| and Regulation | General & Plastic | ||
| Surgery | |||
| 21 CFR 878.4400 | |||
| GEI - Electrosurgical, | |||
| Cutting & Coagulation | |||
| & Accessories | |||
| PBX - Massager, | |||
| Vacuum, | |||
| Radiofrequency | |||
| Induced Heat | General & Plastic Surgery | ||
| 21 CFR 878.4400 | |||
| GEI - Electrosurgical, | |||
| Cutting & Coagulation & | |||
| Accessories | General & Plastic Surgery | ||
| 21 CFR 878.4400 | |||
| GEI - Electrosurgical, Cutting & | |||
| Coagulation & Accessories | |||
| PBX - Massager, Vacuum, | |||
| Radiofrequency Induced Heat | |||
| Indications for | |||
| Use | BTL-499 is indicated to | ||
| be used for: | |||
| Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the abdomen. Reduction in | |||
| circumference of | |||
| the abdomen. Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the thighs. Reduction in | |||
| circumference of | |||
| the thighs. BTL-499 is | |||
| intended for use | |||
| with skin types | |||
| I – VI. Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the flanks | |||
| limited to skin | |||
| types I - IV. Non-invasive | BTL-899F is indicated to be | ||
| used for: | |||
| Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the abdomen. Reduction in | |||
| circumference of | |||
| the abdomen. Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the thighs. Reduction in | |||
| circumference of | |||
| the thighs. BTL-899F is | |||
| intended for use | |||
| with skin types | |||
| I – VI. Non-invasive | |||
| lipolysis | |||
| (breakdown of fat) | |||
| of the flanks | |||
| limited to skin | |||
| types I - IV. Non-invasive | The BTL-785X device has the | ||
| following indications for use: |
The BTL-785X with BTL-785-1
applicator is intended to provide
heating for the purpose of
elevating tissue temperature for
selected medical conditions
such as temporary relief of pain,
muscle spasms, and increase in
local circulation.
The BTL-785-1-4 massage
device is intended to provide
a temporary reduction in the
appearance of cellulite. |
| | (breakdown of fat)
of the upper arms
limited to skin types
II and III and
BMI 30 and under.
The BTL-499 is intended
to provide heating for the
purpose of elevating
tissue temperature for
selected medical
conditions such as
temporary relief of pain,
muscle spasms, and
increase in local
circulation.
The BTL-499 massage
function is intended to
provide a temporary
reduction in the
appearance of cellulite. | (breakdown of fat)
of the upper arms
limited to skin types
II and III and
BMI 30 and under | |
| Electrical
Protection | Class II, BF | Class II, BF | Class II, BF |
| Clinical Use | Prescription use | Prescription use | Prescription use |
| Interface | Touch screen | Touch screen | Touch screen |
| Type of Energy | The system combines
bipolar radiofrequency
with electromagnetic
stimulation and
mechanical massage. | The system combines
bipolar radiofrequency with
electromagnetic stimulation. | The system combines
radiofrequency with mechanical
massaging of body parts with
massage attachment. |
| Source of
electro-
magnetic
stimulation | Single magnetic coil | Single magnetic coil | N/A |
| Number of
output
channels | 2 | 2 | N/A |
| Color Touch
Screen | 15.6 in
39.6 cm
1920x1080 pixels | 15.6 in
39.6 cm
1920x1080 pixels | 15.6 in
39.6 cm
1920x1080 pixels |
| Type of
Operation | Continuous | Continuous | Continuous |
| Pulse
Repetition
Rate -
supported by
the device | 1 – 150 Hz | 1 – 150 Hz | N/A |
| Magnetic Field
Intensity | 499-AP-MRA-1 -
0.5 to 1.8 T
499-AP-MR-2 - 0.7 to 2.0 T
499-AP-MRA-4/5 -
0.35 to 1.3 T | AP-C-1 -
0.5 to 1.8 T
AP-C-2 - 0.7 to 2.0 T
AP-C-4/5 -
0.35 to 1.3 T | N/A |
| Pulse Duration | 499-AP-MRA-1 -
255 µs ± 20%
499-AP-MR-2 -
190 µs ± 20%
499-AP-MRA-4/5 -
245 µs ± 20% | AP-C-1 -
280 µs ± 20
AP-C-2 -
190 µs ± 20%
AP-C-4/5 -
260 µs ± 20% | N/A |
| Pulse
Amplitude | 0—100 % | 0—100 % | N/A |
| Shape of
Stimulation
Pulse | Sine, biphasic | Sine, biphasic | Sine, biphasic |
| Type of Pulse | bipolar | bipolar | Monopolar |
| Max. RF Power | 60W (2x30 W) | 60W (2x30 W) | 140W |
| RF Frequency | 27.12 Mhz | 27.12 Mhz | 3.2 MHz |
| Temperature
Sensor | Yes | Yes | Integrated thermometer +
patient's feedback |
| Selection of
parameters
(Intensity,
Time) | Yes | Yes | Yes |
| Types of
applicators | 3 | 3 | 1 |
| Therapy Time | Up to 30 min | Up to 30 min | Up to 30 min |
| Application | Hands-free, applicator
fixed by fixation belt | Hands-free, applicator fixed
by fixation belt | Manual application of the
therapy and massage |
| Massage
frequency | 0 — 40Hz | N/A | Manual application via attached
massage device |
| Massage
intensity | 0 - 100% | N/A | Manual application via attached
massage device |
| Energy Source | 100 - 240 V AC,
50—60 Hz | 100 - 240 V AC,
50—60 Hz | 100-120 V AC /
200-240 V AC, 50/60 Hz |
| System
Dimensions | 23 x 52 x 35 in
(593 x 1313 x 894 mm) | 23 x 39 x 29 in
(592 x 985 x 730 mm) | 26 x 26 x 54 in
(670 x 670 x 1370 mm) |
| System Weight | 76 kg | 85 kg | 65 kg |
| Operating
Ambient
Temperature | +10°C to +30°C | +10°C to +30°C | +18 °C to +30 °C |
| Operating
Relative
Humidity | 30% to 75% | 30% to 75% | 30% to 75% |
| Environmental
Specifications | For indoor use only
In vertical position – | For indoor use only
In vertical position – On | For indoor use only
In vertical position - On castors |
510(k) Summary Page 4 of 8
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three overlapping squares, each with the letters "BTL" inside.
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL". The squares are arranged in a staggered formation, with the first square slightly higher than the second, and the second square slightly higher than the third. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
9
Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
10
Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three interlocking squares, with the letters "BTL" inside the leftmost square. The text "BTL Industries" is written in a sans-serif font and is also blue.
Substantial Equivalence
The BTL-499 device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL-499 device. Any differences between the predicate devices and BTL-499 have no significant influence on safety and effectiveness of the BTL-499 device. Therefore, the BTL-499 is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-499 device has been shown to be substantially equivalent to currently marketed predicate devices.