(57 days)
Not Found
No
The summary describes a radiofrequency energy delivery system and accessories for electrocoagulation and lesion creation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for electrocoagulation, hemostasis, and to create lesions in nervous tissue, which are therapeutic medical procedures.
No
The device is used for electrocoagulation, hemostasis, and creating lesions in nervous tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states that the device consists of physical accessories (electrodes, cannula, adapter cable) designed to work with a generator, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed on the patient (dermatological and general surgical procedures, creating lesions in nervous tissue). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device description focuses on delivering radiofrequency energy for therapeutic purposes, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is clearly intended for therapeutic and surgical applications directly on the patient's body.
N/A
Intended Use / Indications for Use
The Thermi RF accessories 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 RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).
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)
Electrical safety testing was conducted on the Thermi Symphony RF accessories and Thermi RF Generator. Compliance was shown 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 was performed on the Thermi RF Accessories to verify all design specifications (including the following): temperature measurement, tensile strength, functional testing, design features, heat shrink, active tip length, packaging, and shelflife.
Functional and Simulated Use Verification was also completed to show that the Thermi RF Accessories when used with the Thermi RF Generator, will function as intended.
The Thermi RF accessories met all performance and functional testing and performed as intended.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2016
Thermi Ms. Carrie Eddings Regulatory Manager 8304 Esters Blvd Ste 890 Irving, Texas 75063
Re: K161661
Trade/Device Name: Thermi RF Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2016 Received: June 16, 2016
Dear Ms. Eddings:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
Christopher J. Ronk -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) K161661
Device Name Thermi RF Accessories
Indications for Use (Describe)
The Thermi RF accessories 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5: 510(k) SUMMARY
I. SUBMITTER
Thermi
8304 Esters Boulevard Ste 890 Irving, TX 75063 Telephone: 214-612-5819 Fax: 214-279-0101
Contact Person: Ms. Carrie Eddings, BA Regulatory Manager Contact Telephone: 214-612-5819 Contact Email: ceddings@thermi.com Date Prepared: May 24, 2016
II. DEVICE
Name of Device: Thermi RF Accessories Common or Usual Name: Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI
III. PREDICATE DEVICE
Thermi RF Generator and Accessories, K130689 NeuroTherm ElectroThermal 20S, K033981
IV. DEVICE DESCRIPTION
The Thermi RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).
V. INDICATIONS FOR USE
The Thermi RF accessories 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.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of both the subject and predicate devices are identical since the accessories currently used with the Thermi RF Generator have been manufactured by St. Jude Medical Inc. (formerly NeuroTherm) and marketed under Thermi's 510(k) clearance (K130689). St. Jude Medical Inc. will begin private labeling these devices for Thermi, and as such, Thermi is submitting this 510(k) to obtain its own clearance for these devices. There are no design or manufacturing changes, other than manufacturing location (equipment being moved from Wilmington, MA to Minnetonka, MN), and the reflective labeling changes. The Thermi RF Accessories are substantially equivalent to the NeuroTherm accessories cleared under Thermi 510(k) K130689 and NeuroTherm 510(k) K033981, in terms of indications for use and functional performance.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety
Electromagnetic Compatibility and Electrical safety testing was conducted on the Thermi Symphony RF accessories and Thermi RF Generator. Compliance was shown 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
Bench testing was performed on the Thermi RF Accessories to verify all design specifications (including the following): temperature measurement, tensile strength, functional testing, design features, heat shrink, active tip length, packaging, and shelflife.
Functional and Simulated Use Verification was also completed to show that the Thermi RF Accessories when used with the Thermi RF Generator, will function as intended.
The Thermi RF accessories met all performance and functional testing and performed as intended.
VIII. CONCLUSIONS
The Thermi RF Accessories passed all electrical safety and verification testing, and no new issues of safety or efficacy were raised. The testing demonstrates the Thermi RF Accessories can be safely and effectively used with the 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 RF Accessories is substantially equivalent to the NeuroTherm RF Accessories for the generator.