(336 days)
No
The description focuses on electrical pulse generation and delivery, and ECG synchronization, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
Yes
The device is indicated for the surgical ablation of soft tissue, which is a therapeutic intervention for medical conditions.
No
This device is an ablation generator used for surgical procedures on soft tissue, not for diagnosis. It is intended to destroy tissue, not gather information about a patient's condition.
No
The device description explicitly details hardware components including a generator, foot switch, power cord, and probes (monopolar and bipolar). It also describes the physical interaction of these components with tissue for ablation and coagulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated intended use is "surgical ablation of soft tissue." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a generator and probe used to deliver electrical pulses or radiofrequency energy to soft tissue for ablation. This is a treatment modality, not a diagnostic tool.
- Working Principle: The working principles described (creating perforations for cell apoptosis or generating heat for tissue necrosis) are mechanisms for destroying tissue, which is a therapeutic action.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the device is designed and intended for a surgical, therapeutic procedure (soft tissue ablation) performed directly on a patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.
The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
OAB, GEI
Device Description
The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.
The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.
The Irreversible Electroporation Ablation Generator has three working modes:
- A Mode 1: Monopolar steep pulse mode;
- A Mode 2: Bipolar steep pulse mode;
- A Mode 3: Needle Track Coagulation.
Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.
The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.
Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Non-clinical tests were conducted to verify that the subject devices met all design specifications and is substantially equivalent to the predicate.
Ex-vivo tissue testing using swine muscle tissue, liver tissue and kidney tissue was performed. The result showed the ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device. ECG trigger mode testing was conducted to compare ECG synchronization trigger mode of subject to that of the predicate device.
In-vivo animal (swine) testing was conducted to compare the subject device group and predicate device group in following aspects: blood routine, blood biochemistry, myocardial enzymes and the diameter of ablation. The long ablation diameter and short ablation diameter of subject device group was compared to those of predicate device.
The test results demonstrated that the proposed device complies with the following standards:
- A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- A IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-2-2 Edition 6.0 2017-03 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
- A IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
- A Chinese Pharmacopoeia (2020 version) Bacteria Endotoxins Test
- A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- A ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ISO 11137-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
No clinical data was provided.
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.
Nanoknife system (K183385)
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.
The VIVA combo RF System (K163450)
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 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
June 8. 2023
Zhejiang CuraWay Medical Technology Co., Ltd. Xiaoyu Guan Regulatory Affairs Manager Building 1, No.600, 21st street, Qiantang New Area Hangzhou, Zhejiang 310018 China
Re: K222001
Trade/Device Name: Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OAB Dated: May 8, 2023 Received: May 8, 2023
Dear Xiaoyu Guan:
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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.06.08 11:40:14 -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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Irreversible Electroporation Ablation Generator Irreversible Electroporation Probe
Indications for Use (Describe)
The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.
The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.
| 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
K222001 510(K) Summary
| Company Name/Owner | Zhejiang CuraWay Medical Technology Co., Ltd. |
|---|---|
| Contact person/Author | Xiaoyu Guan(Miss) |
| Date prepared | 06/06/2023 |
| Contact details Address | Room 106, Building 1, No. 600, 21st Avenue, Baiyang |
| Sub-district, Qiantang New District, 310018, Hangzhou | |
| City, Zhejiang Province, China | |
| Trade name | Irreversible Electroporation Ablation Generator |
| Irreversible Electroporation Probe | |
| Common name | Low energy direct current ablation device |
| Classification name | Low Energy Direct Current Thermal Ablation System |
| Review panel | General & Plastic Surgery (SU) |
| Regulation number | 878.4400 |
| Product code | OAB |
| Predicate device | Nanoknife system (K183385) |
| Reference device | The VIVA combo RF System (K163450) |
4
Device Description
The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.
The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.
The Irreversible Electroporation Ablation Generator has three working modes:
- A Mode 1: Monopolar steep pulse mode;
- A Mode 2: Bipolar steep pulse mode;
- A Mode 3: Needle Track Coagulation.
Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.
The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.
Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.
Indications for use
The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissues.
The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation Ablation Generator of CuraWay indicated for the surgical ablation of soft tissue.
5
Substantial equivalence comparison with predicate device
Detailed substantial comparison was made between subject device and predicate device. Please refer to below tables for details.
6
Substantial equivalence Comparison table
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | ||
|---|---|---|---|---|---|---|
| Classification Regulation | 878.4400 | 878.4400 | 878.4400 | Identical | ||
| Product Code | OAB, GEI | OAB | GEI | Identical | ||
| 510(k) Number | - | K183385 | K163450 | Identical | ||
| Indications for use | The Irreversible | |||||
| Electroporation Ablation | ||||||
| Generator is indicated for the | ||||||
| surgical ablation of soft | ||||||
| tissues. | The NanoKnife System with | |||||
| six outputs is indicated for | ||||||
| the surgical ablation of soft | ||||||
| tissue. | The VIVA combo RF | |||||
| System is intended | ||||||
| for use in | ||||||
| percutaneous and | ||||||
| intraoperative | ||||||
| coagulation and | ||||||
| ablation of tissue. | Identical | |||||
| Principle | The Irreversible | |||||
| Electroporation Ablation | ||||||
| Generator has three working | ||||||
| modes: Monopolar steep | ||||||
| pulse mode (Mode 1), Bipolar | ||||||
| steep pulse mode (Mode 2) | ||||||
| and Needle Track Coagulation | ||||||
| (Mode 3). | ||||||
| Mode 1 and Mode 2 are used | The Nanoknife System uses | |||||
| a series of microsecond | ||||||
| electrical pulses to open | ||||||
| "pores" in the cell | ||||||
| membranes. The electrical | ||||||
| pulses are delivered | ||||||
| through several needle-like | ||||||
| probes placed into or | ||||||
| around the ablation zone | ||||||
| under CT or ultrasound | The RF generator | |||||
| works at 500kHz. | ||||||
| The frequency flows | ||||||
| to the electrode's | ||||||
| tip and then is | ||||||
| applied to the | ||||||
| tissue. Frictional | ||||||
| heat occurs and | ||||||
| causes the ions to | ||||||
| move from the | Identical | |||||
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | ||
| for soft tissue ablation, the | ||||||
| working principle is that the | ||||||
| generator transfers | ||||||
| non-thermal energy to | ||||||
| electrodes which are placed at | ||||||
| the target area, it will release | ||||||
| high-voltage electrical pulses | ||||||
| forming nano-scale | ||||||
| permanent perforations on | ||||||
| the soft tissues to disrupt the | ||||||
| intracellular balance and | ||||||
| induce cell apoptosis. The cells | ||||||
| die and are removed by the | ||||||
| human body's own lymphatic | ||||||
| system. | guidance. By applying | |||||
| enough high voltage | ||||||
| energy, the open pores | ||||||
| cause irreversible damage | ||||||
| to the cells. The cells die | ||||||
| and are removed by the | ||||||
| human body's own | ||||||
| lymphatic system. | negative pole to the | |||||
| positive pole and | ||||||
| from the positive | ||||||
| pole to the negative | ||||||
| pole forty to | ||||||
| fifty thousand times | ||||||
| per second. Tissue | ||||||
| necrosis is the | ||||||
| principle that | ||||||
| occurs by using | ||||||
| heat generated | ||||||
| from the tissue | ||||||
| impedance. | ||||||
| The Mode 3 is used for the | ||||||
| soft tissue coagulation during | ||||||
| the process when the probe is | ||||||
| pulled out. This module works | ||||||
| at 480kHZ, the high frequency | ||||||
| flows to the probe's tip and | ||||||
| then is applied to the tissue. | ||||||
| Frictional heat occurs and | ||||||
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | ||
| causes the ions to move from | ||||||
| the negative pole to the | ||||||
| positive pole and from the | ||||||
| positive pole to the negative | ||||||
| pole 40,000 to 50,000 times | ||||||
| per second. Tissue necrosis is | ||||||
| the principle that occurs by | ||||||
| using heat generated from the | ||||||
| tissue impedance. | ||||||
| Working mode | Mode 1: Monopolar steep | |||||
| pulse mode | ||||||
| Mode 2: Bipolar steep pulse | ||||||
| mode | ||||||
| Mode 3: Needle track | ||||||
| coagulation | Steep pulse mode | Coagulation | Identical | |||
| Prescription or OTC | Prescription | Prescription | Prescription | Identical | ||
| Component | Irreversible Electroporation | |||||
| Ablation Generator, | ||||||
| electroporation probes, | ||||||
| neutral electrode, foot switch | NanoKnife Generator, | |||||
| Electrode Probes, Foot | ||||||
| Pedal | Electrosurgical unit, | |||||
| active electrode, | ||||||
| grounding pad, | ||||||
| peristaltic pump | ||||||
| and foot | ||||||
| pedal | ||||||
| ESU | Bipolar or monopolar | Bipolar and Monopolar | Bipolar | Monopolar | Different. The | |
| subject device has | ||||||
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | ||
| two | ||||||
| configurations. It | ||||||
| does not impact | ||||||
| device safety and | ||||||
| effectiveness | ||||||
| Pulse Amplitude/Voltage | ||||||
| output | 500 ~ 3000V | 500 ~ 3000V | N/A, no pulse mode | Identical | ||
| Pulse amplitude precision | $\pm$ 5% | $\pm$ 5% | N/A, no pulse mode | Identical | ||
| Pulse mode | ~50A | ~50A | N/A, no pulse mode | Identical | ||
| Maximum | ||||||
| Output | ||||||
| Current | Needle | |||||
| Track | ||||||
| Coagulation | ||||||
| Mode | 1A | N/A | 2A | Different. The | ||
| working current is | ||||||
| less than that of | ||||||
| the Reference | ||||||
| device. | ||||||
| Pulse width | monophasic | |||||
| pulse mode | 20 ~ 120μs | 20 ~ 100μs | N/A, no pulse mode | Different. The | ||
| pulse width of | ||||||
| monopolar mode | ||||||
| is wider than that | ||||||
| of predicate | ||||||
| biphasic | ||||||
| pulse mode | 5 ~ 40μs | N/A, no biphasic | ||||
| configuration | N/A, no pulse mode | device. Animal | ||||
| test results | ||||||
| provided to |
7
8
9
10
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | |
|---|---|---|---|---|---|
| demonstrate | |||||
| equivalence. | |||||
| Pulse width precision | ±2µs or ±2%(whichever is | ||||
| larger) | ±2µs or ±2% (whichever is | ||||
| larger) | N/A,no pulse mode | Identical | |||
| Number of pulse(s) | 1 ~ 200 | 10 ~ 100 | N/A, no pulse mode | Different. The | |
| difference is | |||||
| between | |||||
| allowable | |||||
| adjustment range | |||||
| Volts/cm | 500 ~ 3000 | 500 ~ 3000 | N/A, no pulse mode | Identical | |
| Maximum probes | 6 | 6 | N/A, no pulse mode | Identical | |
| Pulse frequency, Un-sync | 30~ 240PPM/every 10 pulse | 240PPM/every 10 pulse | |||
| 90PPM/every 10 pulse | N/A, no pulse mode | Different. The | |||
| highest pulse | |||||
| frequency of | |||||
| subject device is | |||||
| same as that of | |||||
| predicate device. | |||||
| Comparison Elements | Subject Device | Predicate Device | Reference Device | Comment | |
| Pulse frequency, Sync | ECG, frequency varies | ||||
| depending on heart rate, | |||||
| ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity |
- A ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
16
- A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
- A Chinese Pharmacopoeia (2020 version) Bacteria Endotoxins Test
- A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- A ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ISO 11137-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Clinical data
No clinical data was provided.
Conclusion
The indications for use of subject device are equivalent to the predicate device. The standards testing and nonclinical performance testing demonstrates the subject device technological characteristics are equivalent to the predicate device for general soft tissue electroporation. In conclusion, the subject device is substantially equivalent to the predicate device.