(83 days)
The Surns Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
Surn5 electrosurgical argon beam Generator and accessories have Monopolar Pure cut, Monopolar Bland Cut, Argon Beam, Bipolar functions. Surn5 electrosurgical argon beam Generator and accessories consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the device. The output is controlled by foot or hand switch.
This document K203522 is a 510(k) premarket notification for an electrosurgical argon beam generator. This specific device is regulated under 21 CFR 878.4400, "Electrosurgical Cutting and Coagulation Device and Accessories," which falls under Class II.
The document does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for medical imaging. Instead, it discusses the safety and effectiveness testing for an electrosurgical device, primarily focusing on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested criteria regarding AI/ML performance, sample sizes for data sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable to the content provided in this 510(k) summary.
However, I can extract the information that is present regarding the non-clinical acceptance criteria and the tests performed.
1. Table of acceptance criteria and the reported device performance:
The document outlines the non-clinical performance tests performed. While it doesn't provide specific quantitative acceptance criteria or detailed numerical results, it lists the standards to which the device was tested and states that the tests were "successfully completed."
| Test Category | Acceptance Standard (Implicitly met if "successfully completed") | Reported Device Performance |
|---|---|---|
| General Safety Testing | IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part 1 General requirements for basic safety and essential performance | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for basic safety and essential performance. |
| EMC Safety Testing | IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part 1-2 General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for electromagnetic compatibility. |
| HF Safety Testing | IEC 60601-2-2:2017 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 | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for high-frequency surgical equipment safety and performance. |
| Performance Testing | Applicable parts of FDA Guidance Document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”, May 2016 | "Medrange completed successfully the following non-clinical performance tests" - implying the device met the performance requirements outlined in the FDA guidance for electrosurgical devices. |
| Usability Testing | IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6 General requirements for safety - Collateral Standard: Usability | "Medrange completed successfully the following non-clinical performance tests" - implying the device met the usability requirements, ensuring that the device can be used safely and effectively as intended. The "software data" mentioned in the statement of substantial equivalence would likely fall under this, or be part of performance testing. |
Summary Judgement on Acceptance: The document states that the tests were "successfully completed" and concludes that the device is "as safe and effective as the predicate device," thus fulfilling "the requirements of a substantially equivalent device."
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable in the context of this 510(k). The tests are typically conducted on a single prototype or representative units of the device in a laboratory setting, not on a "test set" of patient data or images.
- Data provenance: Not applicable. The tests are in vitro or ex vivo engineering and electrical performance tests, not based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an electrosurgical generator, not an AI/ML algorithm requiring expert annotation of medical images for ground truth. The "ground truth" here refers to established engineering standards and device specifications.
4. Adjudication method for the test set:
- Not applicable. Testing is against predefined electrical, mechanical, and safety standards, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This document concerns a surgical energy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance of the device itself (e.g., power output, frequency, safety features) is tested in a standalone manner against engineering standards.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6) and applicable sections of FDA Guidance Documents ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”).
- Additionally, comparison to a legally marketed predicate device's technological characteristics (e.g., power outputs, waveforms, system voltage) serves as a comparative "ground truth" to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component described, so no "training set."
9. How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
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February 22, 2021
Surnic Corporation Helen Xie RA Assistant 480 Apollo Street, Suite D. Brea, California 92821
Re: K203522
Trade/Device Name: Surn5 Electrosurgical Argon Beam Generator and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 29, 2020 Received: December 31, 2020
Dear Helen Xie:
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 Actinclude 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
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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-devices/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 (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) K203522
Device Name
Surn5 Electrosurgical Argon Beam Generator and Accessories
Indications for Use (Describe)
The Surns Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
| 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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Image /page/3/Picture/0 description: The image shows the title "510(k) Summary" in a large font. Below the title is a horizontal line, and below the line is the text "Traditional 510(k) Submission". To the left of the title is a black graphic that looks like a check mark.
| K203522Section 5 | |
|---|---|
| Version | 1 |
| Pages | 3 |
| Date | Feb-19-2021 |
1. Submitter Information
| Company: | Surnic Corporation |
|---|---|
| Address: | Suite D, 480 Apollo Street, Brea CA 92821 |
| Contact: | Helen Xie |
| Phone: | 1(909) 859 - 9055 |
| Email: | hx9055@gmail.com |
2. Device Identification
| Common name: | Electrosurgical Generator and Accessories |
|---|---|
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Trade name: | Surn5 Electrosurgical Argon Beam Generator and Accessories |
| Model: | Surn5 |
| Device Class | Class II |
| Product Code: | GEI |
| 21CFR Regulation Number: | 878.4400 |
3. Predicate Device
Product HelixAR ABC Systems 510(K) K172671
4. Device Description
Surn5 electrosurgical argon beam Generator and accessories have Monopolar Pure cut, Monopolar Bland Cut, Argon Beam, Bipolar functions. Surn5 electrosurgical argon beam Generator and accessories consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the device. The output is controlled by foot or hand switch.
5. Indication for use
The Surn5 Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
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6. Substantial Equivalence Discussion
Technological characteristics
| Device | Subject device | Predicate device |
|---|---|---|
| Manufacturer | Surnic Corporation | Conmed Corporation |
| Model | Surn5 Electrosurgical Argon BeamGenerator and Accessories | HelixAR ABC System |
| 510(k) Number | K203522 | K172671 |
| Class | II | II |
| Product Code | GEI | GEI |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Mechanism ofAction | The device generates highFrequency current400-600 kHz | The device generates highFrequency current385-600 kHz |
| System Voltage | 100-240VAC- 50/60Hz | 100-240VAC- 50/60Hz |
| 4 Monopolar Cut Modes | ||
| Max. Power | 320 W (at 300Ω) | 300 W (at 300Ω) |
| Wave Forms | Sinusoidalconstant / modulatedCut / Coag Pulse Phases | Sinusoidalconstant / modulatedCut / Coag Pulse Phases |
| 8 Monopolar Coagulation Modes | ||
| Max. Power | 120 W (at 500Ω) | 120 W (at 500Ω) |
| Wave Forms | Sinusoidalconstant / modulatedCut / Coag Pulse Phases | Sinusoidalconstant / modulatedCut / Coag Pulse Phases |
| Argon Beam | ||
| Max. Power | 150W (at 500Ω) | 150W (at 500Ω) |
| 4 Bipolar Modes | ||
| Max. Power | 100 W (at 100Ω) | 90 W (at 300Ω) |
| Wave Forms | Sinusoidal constant / modulatedPause Phases | Sinusoidal constant / modulatedPause Phases |
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K203522
7. Non-Clinical Performance Data
To demonstrate the safety and effectiveness of Surn5 Electrosurgical Argon Beam Generator and Accessories show substantial equivalence to the predicate device (Surn5 Electrosurgical Argon Beam Generator and Accessories), Medrange completed successfully the following non-clinical performance tests:
| General Safety Testing | IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part 1General requirements for basic safety and essential performance |
|---|---|
| EMC Safety Testing | IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part 1-2General requirements for basic safety and essential performance CollateralStandard: Electromagnetic disturbances - Requirements and tests |
| HF Safety Testing | IEC 60601-2-2:2017 Medical electrical equipment, Part 2-2Particular requirements for the basic safety and essential performance of highfrequency - Surgical equipment and high frequency surgical accessories |
| Performance Testing | Applicable parts of FDA Guidance Document “Premarket Notification(510(k)) Submissions for Electrosurgical Devices for General Surgery”, May2016 |
| Usability Testing | IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6General requirements for safety - Collateral Standard: Usability |
8. Statement of Substantial Equivalence
The Surn5 Electrosurgical Argon Beam Generator and Accessories have the same intended use as the HelixAR, and the same technological characteristics. The non-clinical test results, such as performance data, software data, electrical safety and electromagnetic compatibility data have demonstrated that Surn5 Electrosurgical Argon Beam Generator and Accessories are as safe and effective as the predicate device. Therefore it is concluded, that the Surn5 Electrosurgical Argon Beam Generator and Accessories fulfill the requirements of a substantially equivalent device and that no new questions of safety and effectiveness were raised.
§ 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.