(165 days)
Not Found
No
The description mentions a "built-in algorithm" in Auto Mode, but there is no mention of AI, ML, or any learning capabilities. The algorithms described appear to be rule-based adjustments based on monitored parameters.
Yes
The device is intended for coagulation and ablation of soft tissue, which directly involves treating a medical condition (tumor tissue) to achieve a therapeutic effect (coagulation necrosis).
No
Explanation: The device is an ablation system used for coagulation and ablation of soft tissue, primarily for treating tumors. It uses radiofrequency energy to destroy tissue rather than diagnose conditions.
No
The device description clearly outlines multiple hardware components including a Radio Frequency Generator, Electrode Kits, Temperature Probe, and Foot Switch. While the device is software-driven, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation and ablation of soft tissue." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components (generator, electrodes, probes, etc.) are designed to deliver energy to tissue for therapeutic purposes.
- Mechanism of Action: The description explains how the radiofrequency current causes heating and tissue necrosis within the patient's body.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device performs a therapeutic action in vivo (within the body).
N/A
Intended Use / Indications for Use
The Radio Frequecy Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.
Product codes
GEI
Device Description
The proposed device consists of Radio Frequency Generator, Radio Frequency Electrode Kits, Temperature Probe and Foot Switch. Wherein, the radiofrequency generator integrated with cooling pump is capable of delivering up to 200W while monitoring tissue impedance, tissue temperature and electrode tip temperature during the delivery of the RF energy. The Radio Frequency Electrode Kits consists of Radio Frequency Electrode, introducer, inflow - outflow tubing sets and Return Pad to be used for puncturing the patient's lesion position during operation and also for outputting Radio Frequency energy to ablate the tumor tissue through connection with Radio Frequency Generator. The Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by Radio Frequency energy.
The Radio Frequency generator supplies 470 kHz of radio frequency current, which enters into target tissue of patient, and builds a circuit loop with the Return Pad. The alternating current cause alternating motion of the positive ions in the tumor region. Because of the different size, mass and charge of each ion, the moving speeds of the ions are different, resulting in collision friction and thermal energy. When the temperature is above 50 °C, tumor tissue come into irreversible coagulation necrosis.
lt supports three working modes: Auto Mode, POWER Mode and TEMP Mode.
Auto Mode
The Auto Mode allows the use of 1-3 RF ablation electrodes for ablation. When multiple RF Ablation electrodes are connected, the RF generator will switch between the electrodes for energy output. In Auto Mode, the system automatically adjusts the power output according to the built-in algorithm.
Power mode
In POWER Mode, the RF generator outputs according to the maximum power set by users. In this mode, only single RF electrode is allowed to be used. The RF Electrode is kept below 40°C by means of internal cooling with cooling-water delivers from a peristaltic pump.
Temperature mode
In TEMP Mode, the RF generator detects the temperature of the RF electrode automatically, and adjusts the power output according to the detected temperature. In this mode, "SET POWER(W)" is forbade to set. Single RF electrode is permitted to use. Once the temperature of RF electrode reaches 85℃, a beep sounds. Then users can pull the RF electrode out of patient at a rate of 1centimetre every 2 seconds.
The Radio Frequency Generator is non-sterile, the return pad is non-sterile and for single use, while Radio Frequency Electrode and Temperature Probe are sterile and for single use.
The device is software-driven and the software validation is provided in Section of Software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device.
Key Metrics
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
June 25, 2019
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Grace Guofang Ma Quality Director No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi City Zhejiang, China 315300
Re: K190052
Trade/Device Name: Radio Frequency Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 31, 2018 Received: January 11, 2019
Dear Grace Guofang Ma:
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
1
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 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 medical devices and radiation-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,
Long Chen, 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
Enclosure
2
Indications for Use
510(k) Number (if known) K190052
Device Name Radio Frequency Ablation System
Indications for Use (Describe)
The Radio Frequecy Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.
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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3
Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
3.1 Submitter Information
● 510(k) Submitter/Holder:
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, China
● Contact
Grace Ma Quality Director Telephone: +86-10-64116115 Fax: +86-10-64113261 Email: QARA@surgnova.com
● Date Prepared: November 12, 2018
3.2 Proposed Device Information
Device Common Name: Electrosurgical cutting and coagulation device and accessories Device Trade/Proprietary Name: Radio Frequency Ablation System Model: R150E Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Class: II Panel: General & Plastic Surgery
3.3 Predicate Device
510(k) Number: K052796 Device Trade/Proprietary Name: Cool-tip™ RF Ablation System Common/Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Class: II Panel: General & Plastic Surgery Manufacturer: VALLEYLAB
4
3.4 Device Description
The proposed device consists of Radio Frequency Generator, Radio Frequency Electrode Kits, Temperature Probe and Foot Switch. Wherein, the radiofrequency generator integrated with cooling pump is capable of delivering up to 200W while monitoring tissue impedance, tissue temperature and electrode tip temperature during the delivery of the RF energy. The Radio Frequency Electrode Kits consists of Radio Frequency Electrode, introducer, inflow - outflow tubing sets and Return Pad to be used for puncturing the patient's lesion position during operation and also for outputting Radio Frequency energy to ablate the tumor tissue through connection with Radio Frequency Generator. The Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by Radio Frequency energy.
The Radio Frequency generator supplies 470 kHz of radio frequency current, which enters into target tissue of patient, and builds a circuit loop with the Return Pad. The alternating current cause alternating motion of the positive ions in the tumor region. Because of the different size, mass and charge of each ion, the moving speeds of the ions are different, resulting in collision friction and thermal energy. When the temperature is above 50 °C, tumor tissue come into irreversible coagulation necrosis.
lt supports three working modes: Auto Mode, POWER Mode and TEMP Mode.
Auto Mode
The Auto Mode allows the use of 1-3 RF ablation electrodes for ablation. When multiple RF Ablation electrodes are connected, the RF generator will switch between the electrodes for energy output. In Auto Mode, the system automatically adjusts the power output according to the built-in algorithm.
Power mode
In POWER Mode, the RF generator outputs according to the maximum power set by users. In this mode, only single RF electrode is allowed to be used. The RF Electrode is kept below 40°C by means of internal cooling with cooling-water delivers from a peristaltic pump.
Temperature mode
In TEMP Mode, the RF generator detects the temperature of the RF electrode automatically, and adjusts the power output according to the detected temperature. In this mode, "SET POWER(W)" is forbade to set. Single RF electrode is permitted to use. Once the temperature of RF electrode reaches 85℃, a beep sounds. Then users can pull the RF electrode out of patient at a rate of 1centimetre every 2 seconds.
The Radio Frequency Generator is non-sterile, the return pad is non-sterile and for single use, while Radio Frequency Electrode and Temperature Probe are sterile and for single
5
use.
The device is software-driven and the software validation is provided in Section of Software.
6
3.5 Comparison list of the technological characteristics
| Comparison Elements | Predicate Device
(K052796) | Proposed Device |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Cool-tip™ RF Ablation System | Radio Frequency Ablation System |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Classification | II | II |
| Product Code | GEI | GEI |
| Indications for Use | The Valleylab Cool-tip RF System (generator and
accessories) is intended for the use in percutaneous,
laparoscopic,
intraoperative coagulation and
ablation of tissue, such as partial or complete
ablation of non-resectable liver lesions and osteoid
osteoma tumors within bone. | The Radiofrequency Ablation System is
intended for coagulation and ablation of soft
tissue. It is not intended for use in cardiac
procedures. |
| Component | RF Generator, peristaltic pump, electrodes, inflow
and outflow tubing for electrode cooling, and return
pads | Radio Frequency Generator, Radio Frequency
Electrode Kits, Temperature Probe and Foot
Switch |
| Electrosurgical unit | | |
| Output Parameters | $480KHZ±2%$ | $470KHZ±2%$ |
| Drive on time | Up to 30minutes | Up to 30minutes |
| Maximum power output | Up to 200 watts @50 ohm | Up to 200 watts @50 ohm |
| Voltage Supply | 100-240VAC 50-60 Hz | 100-240VAC 50-60 Hz |
| Active accessary | | |
| Monopolar/Bipolar | Monopolar | Monopolar |
| Antenna Length (mm) | 100, 150, 200, 250 | 70, 150, 200, 250 |
| Exposure Length (mm) | 7, 10, 20, 30 | 5, 7, 10, 15, 20, 30, 40 |
| Outer Diameter (mm) | 1.47 | 1.2, 1.47 |
| Material | Stainless steel 304 | Stainless steel 304 |
| Disposable
/Single-use
Device | The antennas are disposable and are to be used
within a single patient procedure only. | The antennas are disposable and are to be
used within a single patient procedure only. |
| Sterility | The accessories are sterilized with EO(SAL: 10-6) | The accessories are sterilized with EO(SAL:
10-6) |
| Biocompatibility | Patient-contacting materials are biocompatible. | Patient-contacting
materials
are
biocompatible. |
| Device
Temperature
Monitoring | Temperature monitoring features used to ensure
system safety | Temperature monitoring features used to
ensure system safety |
| Neutral electrodes | | |
| Conductive or Capacitive | Conductive | Conductive |
| Patient Contacted Material | Hydrogel | Hydrogel |
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Premarket Notification 510(k) Submission—K190052
8
3.6 Indications for use
The Radio Frequency Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.
3.7 Testing
Non-Clinical Testing
The Radio Frequency Ablation System and Accessories and the predicate device are substantially equivalent in design concepts, technologies and materials. The Radiofrequency Ablation System and Accessories has been designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
• IEC 60601-1: 2005/A1:2012 Medical Electrical Equipment-Part 1: General requirements for safety.
• IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
• IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
•ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
• ISO 11135: 2014 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
The shelf life of Radiofrequency Ablation Electrode Kits and Temperature Probe is 2 years.
The list of non-clinical test performed on the proposed device.
| No. | Test Name |
|---|---|
| 1 | Electrical Safety Test According to IEC 60601-1 |
9
Premarket Notification 510(k) Submission—K190052
| 2 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
|---|---|
| 3 | Performance Test according to IEC 60601-2-2 |
| 4 | System Performance Test |
| 5 | Thermal Effects test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery |
| 6 | Temperature Monitoring test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery |
| 7 | High Frequency Leakage Current Test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery |
| 8 | Shelf Life Test |
| 9 | Package Verification Test according to ISO 11607-1 |
| 10 | Sterilization validation according to ISO 11135 |
| 11 | Irritation, Sensitization, Cytotoxicity, Pyrogenicity, Acute Systemic Toxicity Test according to ISO 10993 |
Clinical Testing
Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device.
3.8 Determination of substantial equivalence
The proposed device is equivalent with respect to the basic system design and function to that of the predicate device. The proposed device isn't the implants and high-risk device. And it doesn't have new intended purposes, new medical, new target populations, and new users and so on. What's more, it can't use the medicinal substances or animal tissues. So differences between the predicate and proposed device do not raise new questions of safety or effectiveness.