(248 days)
Not Found
No
The summary describes a standard electrosurgical generator with microprocessor control and different software versions for power limits. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is used for cutting and coagulation of tissue in surgical applications, which are therapeutic interventions.
No
Explanation: The device is an electrosurgical generator used for cutting and coagulation of tissue, not for diagnosing medical conditions. Its function is therapeutic/surgical.
No
The device description explicitly states it is a "microprocessor controlled, isolated output, high frequency generator" and mentions "hardware" and "control board," indicating it is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "ESU cutting and coagulation" in the operating room for general surgical procedures. This involves direct interaction with tissue for therapeutic purposes.
- Device Description: The description reinforces its function as a "high frequency generator designed for use in cutting and coagulation of tissue."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
This device is an electrosurgical unit (ESU), which is a therapeutic device used in surgery.
N/A
Intended Use / Indications for Use
The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.
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
operating room
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 Testing:
The Energy Generator and the predicate device are substantially equivalent in design concepts and technologies. The Energy Generator 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 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.
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The list of non-clinical test performed on the proposed device.
- Electrical Safety Test According to IEC 60601-1
- Electromagnetic Compatibility Test According to IEC 60601-1-2
- Performance Test according to IEC 60601-2-2
- System Performance Test
- Thermal Effects test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery
Clinical Testing:
Clinical studies were not required to demonstrate the substantial equivalence of the Energy Generator and the predicated device.
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/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
October 25, 2021
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma OARA Director No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi, Zhejiang 315301 China
Re: K210488
Trade/Device Name: Ultrasonic Surgical & Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 10, 2021 Received: August 30, 2021
Dear 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 mediation-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
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Indications for Use
510(k) Number (if known) K210488
Device Name Energy Generator
Indications for Use (Describe)
The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.
**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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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 ●
Guofang Ma QARA Director Telephone: +86-10-64116115 Fax: +86-10-64113261 Email: QARA@surgnova.com
- Date Prepared: October 22, 2021 ●
3.2 Proposed Device Information
Device Common Name: Electrosurgical cutting and coagulation device and accessories Device Trade/Proprietary Name: Energy Generator Model: ES300, ES200, ES100 Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Class: II Panel: General & Plastic Surgery
3.3 Predicate Device
510(k) Number: K944602 Device Trade/Proprietary Name: Valleylab Force Fx Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II Panel: General & Plastic Surgery Manufacturer: VALLEYLAB, INC.
3.4 Device Description
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The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.
The device working mode is shown in the following table:
| Model | Working mode | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Monopolar | Bipolar | ||||||||
| Low pure | |||||||||
| cut | Pure | ||||||||
| cut | Blend | Desiccate | Fulgurate | Spray | Precise | Standard | Macro | ||
| ES300 | √ | √ | √ | √ | √ | √ | √ | √ | √ |
| ES200 | N/A | √ | √ | N/A | √ | √ | N/A | √ | √ |
| ES100 | N/A | N/A | √ | N/A | N/A | √ | N/A | N/A | √ |
ce working mode is shown in the following table:
Table 1 Device working mode
Monopolar
- Low pure cut mode: applicable to cutting of fine tissues and endoscopic surgery ●
- Pure cut mode: applicable to fine non-invasive cutting ●
- Blend mode: providing good coagulant effect when cutting
- . Desiccate mode: applicable to the coagulation of endoscopic surgery and other fine tissues
- . Fulgurate mode: applicable to the superficial coagulation of most surgeries and laparoscopic surgeries
- . Spray mode: applicable to large area of tissue bleeding, and only forming a scab in superficial tissue structure.
Bipolar
- Precise mode: applicable to neurosurgery, ophthalmology and other microsurgeries
- Standard mode: applicable to neurosurgery and general surgeries
- Macro mode: applicable to open and endoscopic surgeries
The monopolar Low pure cut mode, Pure cut mode, Blend mode, Desiccate mode, Fulgurate mode and Spray mode are designed for use with conventional hand switching or foot switching electrosurgical devices. The three bipolar output modes are designed for use with conventional hand switching or foot switching electrosurgical bipolar forceps. When using conventional electrosurgical devices, the user selects the mode and desired power using a touch screen display on the generator.
The monopolar mode requires use of neutral electrode. The Energy Generator can be compatible with neutral electrode based on their output rating with FDA clearance. For
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example: FDA 510k cleared Electorsurgical pad: K130027 or other FDA cleared neutral electrode. Bipolar devices do not require neutral electrode.
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3.5 Comparison list of the technological characteristics
Based on the components of the Energy Generator, the subject device is compared with Valleylab Force Fx (K944602). The technological characteristics, features, specifications and intended use of Energy Generator is substantially equivalent to the predicated devices quoted above. The specific results are as follows:
| Comparison Elements | Subject Device | Predicated device
(K944602) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Energy Generator | Valleylab Force Fx |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Classification | II | II |
| Classification Name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories |
| Indications for Use | The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The ESU generator is equipped with monopolar and bipolar outputs. | The Valleylab Force Fx is an isolated microprocessor based ESU generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The generator is equipped with monopolar and bipolar outputs. |
| Working principle | Monopolar: ESU generator connects its accessories and split ESU neutral electrode (adhered to patient skin) to form a cyclic circuit, the HF current generated | Monopolar: ESU generator connects its accessories of a ESU pencil and a split ESU pad (adhered to patient skin) to form a cyclic circuit, the HF current |
Table 2 Comparison between Energy Generator and Valleylab Force Fx (K944602)
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| | | | from the generator and through the ESU accessories
(such as electrosurgical pencil and laparoscopic
electrode) to achieve CUT or COAG, then return to
generator by the ESU neutral electrode. | generated from the generator and through the ESU
pencil to achieve CUT or COAG, then return to
generator by the ESU pad. |
|----------------------------|----------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Bipolar: HF current generated from the generator and
the cyclic circuit formed between the two tips of the
bipolar forceps, the HF power through the two tips to
work on patient obtaining COAG, no need extra ESU
neutral electrode. | Bipolar: HF current generated from the generator
and the cyclic circuit formed between the two tips of
the bipolar forceps, the HF power through the two
tips to work on patient obtaining COAG, no need
extra ESU pad. |
| Energy | | | HF energy | HF energy |
| Input power | | | 100V -240V AC | 100-120V/220-240V, 60Hz/50Hz |
| Performance Specifications | Waveform | Monopolar
CUT | Low Pure Cut Mode
Pure Cut Mode
Blend Mode | Low Pure Cut Mode
Pure Cut Mode
Blend Mode |
| | | Monopolar
COAG | Desiccate Mode
Fulgurate Mode
Spray Mode | Desiccate Mode
Fulgurate Mode
Spray Mode |
| | | Bipolar | Precise Mode
Standard Mode
Macro Mode | Precise Mode
Standard Mode
Macro Mode |
| | Operation mode | | Intermittent use 10s on, 30s off | Under maximum power settings and rated load
conditions (pure cut 300W, 300ohm load) the
generator is suitable for activation times of 10s on,
30s off for 1 hour |
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| Special function | CQMS | The Neutral Electrode Contact Quality Monitor will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated. | Force FX (REM): The Return Electrode Contact Quality Monitor will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated. |
|---|---|---|---|
| Memory | The previous power setting digits presented when restart | Recall the last activated previous setting when Power On next time by pressing RECALL | |
| Power ON self diagnostics | The generator starts self diagnosis after power on, if the self diagnosis fail, an alarm sounds and an Error Code is displayed on the display panel. | Force Fx: When the generator senses a system alarm conditions, an alarm sounds and an alarm number is displayed on the front panel. A system alarm condition deactivates the generator. | |
| Operating | Only one output device to be activated at any given time | Only one output device to be activated at any given time |
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3.6 Indications for Use
The Eenergy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The ESU generator is equipped with monopolar and bipolar outputs.
3.7 Testing
Non-Clinical Testing
The Energy Generator and the predicate device are substantially equivalent in design concepts and technologies. The Energy Generator 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 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.
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The list of non-clinical test performed on the proposed device.
| No. | Test Name |
|---|---|
| 1 | Electrical Safety Test According to IEC 60601-1 |
| 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 |
Clinical Testing
Clinical studies were not required to demonstrate the substantial equivalence of the Energy Generator and the predicated device.
3.8 Determination of substantial equivalence
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The subject device is equivalent with respect to the basic system design and function to that of the predicate device. The subject 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. So the proposed device is determined to be substantially equivalent to the predicate device.