(59 days)
Not Found
No
The document describes a radiofrequency electrode and cannula system for delivering controlled heat. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies focus on electrical safety and basic functional testing.
Yes.
The device is used in medical procedures for electrocoagulation, hemostasis, and to create lesions in nervous tissue, which directly relate to the treatment of a medical condition or ailment.
No
The device is indicated for therapeutic purposes (electrocoagulation and hemostasis, and creating lesions in nervous tissue) rather than for diagnosing a condition.
No
The device description explicitly details physical components like electrodes, cannulas, insulated shafts, and cables, which are hardware, not software.
Based on the provided text, 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 and hemostasis" and "to create lesions in nervous tissue". These are procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The device is described as an electrode and cannula for "percutaneous application of RF energy" to heat tissue. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply energy directly to tissue for therapeutic or surgical purposes.
N/A
Intended Use / Indications for Use
The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:
- *for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue when used in combination with Thermi RF Generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products.
The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.
The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.
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 following performance data were provided in support of the substantial equivalence determination.
Electrical safety
Electrical safety testing was conducted on the Thermi Injectable RF® Electrodes and ThermiRF Generator. Compliance was demonstrated through testing to IEC 60601-1: 2006, IEC 60601-1-2: 2001, IEC 60601-1-4: 1996, IEC 60601-1-6: 2006 and IEC 60601-2-2: 2009.
Bench testing
A series of bench testing was conducted on the Thermi Injectable RF® Electrodes in accordance with protocols to verify design specifications as follows: dimensional testing, functional testing, design features, tensile strength, packaging, shipping and shelf-life.
The functional and simulated use verification testing was completed to demonstrate that the Thermi Injectable RF® Electrodes will function as intended when used with the Thermi RF Generator.
The results of testing show that the Thermi Injectable RF® Electrodes, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2017
Thermi Ms. Suzanne Cheang Regulatory Affairs Manager 8304 Esters Boulevard Irving, Texas 75063
Re: K170116
Trade/Device Name: Thermi Injectable RF Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and acessories Regulatory Class: Class II Product Code: GEI Dated: December 21, 2016 Received: January 13, 2017
Dear Ms. Cheang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
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
Indications for Use
510(k) Number (if known)
Device Name
Thermi Injectable RF® Electrodes
Indications for Use (Describe)
The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:
- *for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue when used in combination with Thermi RF Generator.
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
SECTION 5: 510(k) SUMMARY
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 8.7.87 and 807.92.
I. SUBMITTER
| Date Prepared | March 09, 2017 |
|---|---|
| Company | Thermi |
| 8304 Esters Boulevard Ste 890 | |
| Irving, TX 75063 | |
| Contact | Ms. Suzanne Cheang, BS |
| Regulatory Affairs Manager | |
| Telephone: 214-888-0683 | |
| Fax: 214-279-0101 | |
| scheang@thermi.com | |
| II. DEVICE | |
| Trade Name | Thermi Injectable RF® Electrodes |
| Common Name | Electrosurgical Cutting and Coagulation Device and |
| Accessories | |
| Classification | |
| Name | 21 CFR 878.4400 Electrosurgical Cutting and Coagulation |
| Device and Accessories | |
| Regulatory Class | II |
| Product Code | GEI |
III. PREDICATE DEVICE
Predicate Name Thermi RF Accessories, K161661
4
IV. DEVICE DESCRIPTION
The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products.
The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.
The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.
V. INDICATIONS FOR USE
The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:
-
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
-
- to create lesions in nervous tissue when used in combination with Thermi RF Generator.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Thermi Injectable RF® Electrodes are substantially equivalent to the Thermi RF Accessories, cleared under 510(k) K161661, in terms of design, functional performance, and intended use. The Thermi Injectable RF® Electrodes combine the separate electrodes and cannulas described in the Thermi RF Accessories 510(k) K161661 into single devices, which reduces procedure steps and time. There is no change to the fundamental scientific technology of the previously cleared devices or their indications for use as compared to the Thermi RF Accessories.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety
Electrical safety testing was conducted on the Thermi Injectable RF® Electrodes and ThermiRF Generator. Compliance was demonstrated through testing to IEC 60601-1: 2006, IEC 60601-1-2: 2001, IEC 60601-1-4: 1996, IEC 60601-1-6: 2006 and IEC 60601-2-2: 2009.
Bench testing
A series of bench testing was conducted on the Thermi Injectable RF® Electrodes in accordance with protocols to verify design specifications as follows: dimensional testing, functional testing, design features, tensile strength, packaging, shipping and shelf-life.
The functional and simulated use verification testing was completed to demonstrate that the Thermi Injectable RF® Electrodes will function as intended when used with the Thermi RF Generator.
The results of testing show that the Thermi Injectable RF® Electrodes, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
VIII. CONCLUSIONS
The results of testing show that the Thermi Injectable RF® Electrodes, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions when use with Thermi RF Generator. The means of achieving electrocoagulation and hemostasis and creating lesions in nervous tissue in dermatological and general surgical procedures with the Thermi Injectable RF® Electrodes is substantially equivalent to the predicate devices.