(106 days)
The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes
The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.
The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.
The provided FDA 510(k) clearance letter describes a medical device, the Boston Scientific GX1 Radiofrequency Generator, and its performance testing. However, the document does not contain information related to acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML components.
The GX1 Radiofrequency Generator is a hardware device used to create radiofrequency lesions, not a software or AI/ML device that would typically have acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC) and require a clinical study with a test set, ground truth, and expert adjudication.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly "Pass" for compliance with electrical safety standards, electromagnetic compatibility, and various design verification tests.
- Reported Device Performance:
| Test Category | Test Method Summary / Specific Tests | Reported Performance |
|---|---|---|
| Electrical Safety | Type testing/conformity testing per IEC 60601-1 Ed. 3.2: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Type testing/conformity testing per IEC 60601-2-2:2017/AMD1:2023, Edition 6.1 – 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 | Pass |
| Electromagnetic Compatibility (EMC) | Type testing/conformity testing per IEC 60601-1-2 Ed. 4.1: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Pass |
| Performance Testing (Bench) | - RF Power vs Load Curve - RF Output Voltage Measurement - RF Output Current Measurement - RF Output Impedance Measurement - RF Ramp Rate Control - Stimulation Output Voltage - Stimulation Output Current - Ablation Temperature Measurement - Contact Quality Measurement | Pass |
| Packaging Testing | Conform to ASTM D4169 Standard Practice for performance testing of shipping containers and systems | Pass |
| Mechanical Testing | - Tamper Resistant screws - Cleaning Test - Drop Test - Impact Test - Flammability - Overbalance - Durable Labels - Ingress Protection - Operational conditions (Temperature, Pressure and Humidity) | Pass |
| Lesion Size Comparison Test | Compare lesions size in homogenous tissue using G4 (Predicate) vs GX1 System | Pass |
| Dimension and Weight | Meet dimensional and weight specifications per product specification | Pass |
| Software Verification | - User Workflow and Information Display - Touch Screen - Error Display - Report/Diagnose Logging - Security - Language Translation - Therapy Template | Pass |
Missing Information (Not present in the provided document):
- Sample size used for the test set and the data provenance: Not applicable for this type of hardware device testing. There isn't a "test set" in the context of clinical data for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is typically established through engineering specifications, calibrated measurements, and adherence to international standards.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used for these technical tests are established engineering specifications, physical measurements, and compliance with recognized industry standards (e.g., IEC standards for electrical safety and EMC, ASTM for packaging).
- The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The Boston Scientific GX1 Radiofrequency Generator underwent a series of non-clinical bench testing to demonstrate its performance, safety, and effectiveness. These tests included:
- Electrical Safety Testing: To ensure compliance with IEC 60601-1 and IEC 60601-2-2.
- Electromagnetic Compatibility (EMC) Testing: To confirm compliance with IEC 60601-1-2.
- Performance Testing: A range of specific tests covering RF power, voltage, current, impedance, temperature measurement/control, stimulation output, contact quality measurement, and lesion size comparison with the predicate device (G4 RF Generator) in "homogenous tissue."
- Packaging Testing: To ensure integrity during shipping.
- Mechanical Testing: Covering various physical durability and environmental factors.
- Software Verification: To confirm user interface, error handling, security, and other software functionalities.
All tests "Passed," indicating that the device met its design input requirements and compliance standards. The study's conclusion was that the GX1 Generator is substantially equivalent to its predicate device (K082051) based on indications for use, technological characteristics, and acceptable results from verification and validation testing.
FDA 510(k) Clearance Letter - K251247
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 7, 2025
Boston Scientific Neuromodulation Corporation
Alex Hoang
Principal Regulatory Affairs Specialist
25155 Rye Canyon Loop
Valencia, California 91355
Re: K251247
Trade/Device Name: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
Regulation Number: 21 CFR 882.4400
Regulation Name: Radiofrequency Lesion Generator
Regulatory Class: Class II
Product Code: GXD
Dated: April 22, 2025
Received: July 7, 2025
Dear Alex Hoang:
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 (the 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 available 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.
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K251247 - Alex Hoang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251247 - Alex Hoang Page 3
assistance/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,
Yen-chih Lin -S (Digitally signed by Yen-chih Lin -S Date: 2025.08.07 07:26:05 -04'00')
For
Adam Pierce
Assistant Director
DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251247
Device Name: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03).
Indications for Use (Describe):
The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
K251247 Page 1 of 6
510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 92355 |
| Correspondent Contact Information: | Alexander Hoang Principal Regulatory Affairs Specialist |
| Registration Number | 3006630150 |
| Device Common Name: | Radiofrequency Ablation Generator |
| Device Regulation & Name: | Radiofrequency Lesion Generator (21 CFR 882.4400) |
| Classification & Product Code: 510(k) Number: | Class II, GXD K251247 |
| Device Proprietary Name: | GX1™ Radiofrequency Generator Kit (RFG-X1-120V) GX1™ Radiofrequency Generator Kit (RFG-X1-220V) GX1™ Radiofrequency Generator Kit (RFG-X1-240V) GX1™ System Release Rest of World(GX1-SYS-ROW) GX1™ Radiofrequency Generator (51779845-01) GX1™ Radiofrequency Generator (51779845-02) GX1™ Radiofrequency Generator (51779845-03) |
Predicate Device Information
| Predicate Device: | G4 Radiofrequency Ablation Generator |
| Predicate Device Manufacturer: | Boston Scientific Neuromodulation Corporation |
| Predicate Device Common Name: | Radiofrequency Ablation Generator |
| Predicate Device Premarket Notification # | K082051 |
| Predicate Device Regulation & Name | Radiofrequency Lesion Generator (21 CFR 882.4400) |
| Predicate Device Classification & Product Code: | Class II GXD |
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K251247 Page 2 of 6
B. Date Summary Prepared
August 4, 2025
C. Description of Device
The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.
The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.
D. Indications for Use
The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes
E. Comparison of the Technological Characteristics
Radiofrequency ablation is the technological principle for both the subject and predicate devices. Both lesion generators supply electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. Both generators have a Graphical User Interface (GUI) that allows the user to control its advanced functionalities. Both generators have a stimulator that enables the user to deliver stimulating current in either Current-controlled or Voltage Controlled mode, according to the physician's preference. The GX1 Generator is substantially equivalent to the existing commercial G4 Generator. The GX1 Generator has the same intended use, scientific technology, design, materials, cleaning and sterilization method, and packaging materials as the applicable predicate device.
| Company | Boston Scientific | Boston Scientific | Comparison |
|---|---|---|---|
| Device | Application Device: GX1 RF Generator | Predicate Device: G4 RF Generator | |
| 510(k) | K251247 | K082051 | -- |
| FDA Classification/ Product Code | II GXD, 882.4400 | II GXD, 882.4400 | Equivalent |
| Intended Use | The generator is intended to be used as a power source to deliver RF energy via compatible RF Electrodes and Cannulas. | Equivalent |
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K251247 Page 3 of 6
| Company | Boston Scientific | Boston Scientific | Comparison |
|---|---|---|---|
| Device | Application Device: GX1 RF Generator | Predicate Device: G4 RF Generator | |
| Indications for Use | The GX1 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes. | The G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The G4 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes. | Equivalent |
| Electrical Supply | |||
| Voltage Specifications | 100/120/220/240 VAC | 100/120/220/240 VAC | Equivalent |
| Max Input Voltage | 260 VAC | 260 VAC | Equivalent |
| Max Input Power | 480 VA | 480 VA | Equivalent |
| Frequency | 50/60 Hz | 50/60 Hz | Equivalent |
| Environmental Operating Range | |||
| Temperature | 15°C–40°C | 15°C–40°C | Equivalent |
| Humidity | 15–80% (non-cond.) | 15–80% (non-cond.) | Equivalent |
| Pressure | 620–1060 hPa | 500–1060 hPa | Different |
| Transport/Storage Range | |||
| Temperature | -29°C–60°C | -29°C–60°C | Equivalent |
| Humidity | 15–80% (non-cond.) | 15–80% (non-cond.) | Equivalent |
| Impedance Monitor | |||
| Range | 0–3000 ohms digital | 0–3000 ohms digital | Equivalent |
| Resolution | 1 ohm (<999), 10 ohm (1–3K) | 1 ohm (<999), 10 ohm (1–3K) | Equivalent |
| Contact Quality Monitoring (CQM) | Yes | no | Different |
| Stimulator Output | |||
| Rate | 2, 5, 50, 75, 100, 150, 180, 200 Hz | 2, 5, 50, 75, 100, 150, 180, 200 Hz | Equivalent |
| Duration | 0.1, 0.5, 1, 2, 3 ms | 0.1, 0.5, 1, 2, 3 ms | Equivalent |
| Voltage-controlled mode | 0–5 V | 0–5 V | Equivalent |
| Current-controlled mode | 0–10 mA | 0–10 mA | Equivalent |
| Parameters | |||
| Timing (Selectable) | 30–1800 sec | 30–1800 sec | Equivalent |
| Resolution | 1 second | 1 second | Equivalent |
| Voltage Range | 0–70 V | 0–70 V | Equivalent |
| Voltage Resolution | 1 volt | 1 volt | Equivalent |
| Current Range | 0–700 mA | 0–700 mA | Equivalent |
| Current Resolution | 1 mA | 1 mA | Equivalent |
| Power Output | 0–50 W | 0–50 W | Equivalent |
| Power Resolution | 0.1 W (<1 W), 1 W (≥1 W) | 0.1 W (<1 W), 1 W (≥1 W) | Equivalent |
| Frequency | 480 kHz ±3% | 480 kHz ±3% | Equivalent |
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K251247 Page 4 of 6
| Company | Boston Scientific | Boston Scientific | Comparison |
|---|---|---|---|
| Device | Application Device: GX1 RF Generator | Predicate Device: G4 RF Generator | |
| Pulsed Mode | |||
| Repetition Rate | 1–10 Hz | 1–10 Hz | Equivalent |
| Duration | 2-50 ms | 2-50 ms | Equivalent |
| Temperature Monitor | |||
| Range | 0–110 °C | 0–110 °C | Equivalent |
| Resolution | 1 °C | 1 °C | Equivalent |
| Temperature Control | |||
| Range | 37–90 °C | 37–90 °C | Equivalent |
| Resolution | 1 °C | 1 °C | Equivalent |
F. Summary of Supporting Data
The following performance data were provided in support of the substantial equivalence determination.
Electromagnetic Compatibility and Electrical Safety Testing:
The GX1 RF Ablation System was evaluated for compliance with the following standards and was found to be complying:
- IEC 60601-1; Medical electrical equipment; Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2; Medical electrical equipment; Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility
- IEC 60601-2-2; 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
| Tests | Test Method Summary | Results |
|---|---|---|
| High Frequency Surgical Equipment and Accessories – Safety Testing | Type testing/conformity testing per IEC 60601-2-2:2017/AMD1:2023, Edition 6.1 – 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. | Pass |
| Medical Electrical Equipment – Safety Testing | Type testing/conformity testing per IEC 60601-1 Ed. 3.2: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Pass |
| Electromagnetic Compatibility | Type testing/conformity testing per IEC 60601-1-2 Ed. 4.1: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential | Pass |
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K251247 Page 5 of 6
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Performance Testing
A range of design verification testing was conducted to confirm the subject devices perform as intended and are safe and effective for their intended use. Results of performance testing are summarized below.
| GX1 RF Ablation System Test | Test Summary | Results |
|---|---|---|
| Design Verification Testing | - RF Power vs Load Curve- RF Output Voltage Measurement- RF Output Current Measurement- RF Output Impedance Measurement- RF Ramp Rate Control- Stimulation Output Voltage- Stimulation Output Current- Ablation Temperature Measurement- Contact Quality Measurement | Pass |
| Packaging Testing | Conform to ASTM D4169 Standard Practice for performance testing of shipping containers and systems | Pass |
| Mechanical Testing | - Tamper Resistant screws- Cleaning Test- Drop Test- Impact Test- Flammability- Overbalance- Durable Labels- Ingress Protection- Operational conditions(Temperature, Pressure and Humidity | Pass |
| Lesion Size Comparison Test | Compare lesions size in homogenous tissue using G4 (Predicate) vs GX1 System | Pass |
| Dimension and Weight | Meet dimensional and weight specifications per product specification | Pass |
| Software Verification | - User Workflow and Information Display- Touch Screen- Error Display- Report/Diagnose Logging- Security- Language Translation- Therapy Template | Pass |
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K251247 Page 6 of 6
G. Discussion of Performance Testing
Electrical safety and Electromagnetic compatibility (EMC)
Electrical Testing
Electrical verification testing of relevant components of the GX1 RFG was conducted and demonstrated compliance with current electrical safety standards IEC 60601-1 and IEC 60601-2-2.
Electromagnetic Compatibility (EMC)
EMC testing of relevant components of the GX1 RFG was conducted and demonstrated compliance with current standard IEC 60601-1-2.
Software
Software verification and validation testing were conducted and demonstrated compliance with all software requirements.
Performance Testing - Bench
Non-clinical bench testing included GX1 system verification and validation, packaging verification, and usability studies. Design Verification testing confirmed that all design outputs met the design input requirements. Design Validation testing confirmed that the GX1 RFG conforms to the user needs and intended uses.
H. Conclusion
The results of the EMC, Software, and Performance tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. All testing was completed with acceptable results.
Based on the indications for use, technological characteristics, and results of verification and validation testing, the GX1 Generator has been shown to be appropriate for its intended use and is substantially equivalent to its predicate (K082051).
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).