(307 days)
Not Found
No
The summary describes a standard radiofrequency device with a microprocessor-driven control unit and user interface. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is described as enabling "application of therapy" and its intended use includes "electrocoagulation and hemostasis" and "fractional treatment of the skin," which are therapeutic interventions.
No
The device is described for therapeutic procedures (electrocoagulation, hemostasis, and fractional skin treatment) using a high-frequency field, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a control unit, radiofrequency generator, user interface with touch screen, applicator, and exchangeable applicator tips.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dermatological and general surgical procedures for electrocoagulation, hemostasis, and fractional treatment of the skin. These are all procedures performed directly on the patient's body.
- Device Description: The device applies a high-frequency field and uses an applicator with exchangeable tips to deliver therapy. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to treat the body directly.
N/A
Intended Use / Indications for Use
The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.
Product codes
GEI
Device Description
The BTL-FR2000 device enables application of therapy by a high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with button, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip. The BTL-FR2000 device comes with two types of the applicator, depending on the applicator tip attached - Applicator 786-1 and Applicator 786-2. The BTL-FR2000 device consists of the following main components: microprocessor-driven control unit, radiofrequency generator, user interface with 8.4" color touch screen, applicator for an application of radiofrequency, and exchangeable applicator tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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-FR2000 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, ISO 14971, ISO 10993-1, ISO 11135. Bench testing has been performed in order to demonstrate the device is able to achieve required temperature in the treated area.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows 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.
December 13, 2018
BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K180359
Trade/Device Name: BTL-FR2000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 8, 2018 Received: November 13, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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.
Long H.
Chen -S
Digitally signed by
Long H. Chen -S
Date: 2018.12.13
13:27:30 -05'00'
for
Binita S. Ashar. M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180359
Device Name BTL-FR2000
Indications for Use (Describe)
The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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 Druq 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."
Type of Use (Select one or both, as applicable)
3
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180359
Device Name BTL-FR2000
Indications for Use (Describe)
The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.
| 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 Druq 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."
4
Image /page/4/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are stacked on top of each other. The letters "BTL" are written in white inside the top square. To the right of the squares, the words "BTL Industries" are written in gray.
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 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 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: | December 13, 2018 |
Device
| Trade/Proprietary Name: | BTL-FR2000 |
|---|---|
| Primary Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification Regulation: | 21 CFR 878.4400, Class II |
| Classification Product Code: | GEI |
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Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side, with the letters "BTL" inside the leftmost square. To the right of the squares, the words "BTL Industries" are written in a gray, sans-serif font.
Legally Marketed Predicate Devices
The BTL-FR2000 is a state-of-the-art radiofrequency device with accessories. The device is substantially equivalent to the products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
Product Description
The BTL-FR2000 device enables application of therapy by a high-frequency field.
The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with button, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip.
The BTL-FR2000 device comes with two types of the applicator, depending on the applicator tip attached - Applicator 786-1 and Applicator 786-2.
The BTL-FR2000 device consists of the following main components:
- microprocessor-driven control unit .
- . radiofrequency generator
- user interface with 8.4" color touch screen ●
- . applicator for an application of radiofrequency
- . exchangeable applicator tips
Intended Use
The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.
Performance Data
The BTL-FR2000 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
6
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility – Requirements and tests |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgery
equipment and high frequency surgical accessories |
| 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 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements
for the development, validation and routine control of a sterilization
process for medical devices |
Bench testing has been performed in order to demonstrate the device is able to achieve required temperature in the treated area.
Technological Characteristics
The BTL-FR2000 device has similar technological characteristics compared to its predicate devices. The BTL-FR2000 device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touchscreen control panel. The applicator is used with exchangeable tips as by predicates.
The energy source of the BTL-FR2000 device is 100 - 240 V AC, 50 - 60 Hz, alike the predicate devices. BTL-FR2000 electrical protection is classified as Class II, BF and it assures high level of electric shock protection.
Type of energy applied is identical to the devices being compared, the electromagnetic energy is used to achieve the intended use. The RF signal frequency of 1 MHz is also identical. The difference between BTL-FR2000 device and predicate devices is in mode of operation. The BTL-FR2000 device use monopolar mode of operation, compared to the bipolar mode by predicate devices. Nevertheless, monopolar mode of operation is also used by devices with similar intended use, cleared by the FDA. Moreover above mentioned bench testing has been conducted to verify the device is able to achieve required temperature in the treated area. Therefore the differences does not rise any new questions of safety nor effectiveness.
The BTL-FR2000 device, as well as the predicate devices, uses sterile exchangeable tips. The material used for production of superficial pins and needles is gold, identical material for the devices being compared. The depth of micro-needle electrodes of BTL-FR2000 device, 0.5 - 3.5mm is also identical to predicate device. The needle spacing of 1.7mm is comparable to the predicate devices. The tips size of compared devices slightly differ, but this difference does not rise any new questions of safety nor effectiveness.
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Image /page/7/Picture/1 description: The image contains 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 gray, sans-serif font. The text is slightly spaced out, giving it a modern and clean appearance.
Furthermore, technological differences in the shape and dimensions of the BTL-FR2000 device console and predicate devices also do not raise any safety or effectiveness questions, given that the BTL-FR2000 device console design was previously cleared.
Therefore, the BTL-FR2000 device has similar technological characteristics compared to its predicate devices.
Substantial Equivalence
The BTL-FR2000 device has similar intended use and technological characteristics to the predicate devices. Any differences between the predicate devices and BTL-FR2000 device have no significant influence on safety or effectiveness of the BTL-FR2000 device. Therefore, the BTL-FR2000 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-FR2000 device has been shown to be substantially equivalent to currently marketed predicate devices.