(181 days)
No
The device description and performance studies focus on the hardware components, radiofrequency ablation process, and standard electrical/mechanical testing. There is no mention of AI, ML, or any data-driven decision-making or analysis within the device's operation.
Yes
The device is indicated for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures, which directly addresses a medical condition by ablating specific tissue.
No
The device is indicated for the creation of radiofrequency lesions in nervous tissue, which is a therapeutic procedure, not a diagnostic one. While it mentions "diagnostically locating the area to ablate," this diagnostic function is performed by sEEG, which then functions as an sEEG-RF Probe for ablation, indicating the system's primary role is therapeutic.
No
The device description explicitly lists multiple hardware components including a generator, cables, probes, and accessories, indicating it is a hardware-based system with potentially integrated software.
Based on the provided information, the NeuroOne OneRF Radiofrequency Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device components and their function involve delivering radiofrequency energy to tissue within the patient's body to create lesions. This is an in vivo procedure.
- Anatomical Site: The device is used on "Nervous tissue," which is within the patient's body.
- Mechanism of Action: The device uses radiofrequency ablation to directly modify tissue within the patient. IVDs, on the other hand, analyze samples (like blood, urine, tissue) to provide diagnostic information.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NeuroOne OneRF system does not fit this definition. It is a therapeutic device used for surgical intervention.
N/A
Intended Use / Indications for Use
The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GXD, GXI
Device Description
The OneRF Ablation System components consist of the:
- Radiofrequency (RF) Generator and Accessories
- Generator Interface Cable (GIC), Cart and Foot Pedal (optional)
- sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
- Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box
The OneRF Ablation System uses radiofrequency ablation to create lesion(s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.
To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nervous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons familiar with RF lesion techniques
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)
The NeuroOne OneRF Ablation System underwent non-clinical performance testing.
- Lesion Size Testing: Provided a measurement of the size (width and length) of the lesion for each active electrode contact based on temperature, time, and configuration (monopolar, bipolar), and mode (temperature control, manual).
- Results: Lesion sizes were determined based on time and temperature. Lesion size is comparable to predicate.
- Dimensional Verification and RFCB Cable Durability: Evaluated dimensional characteristics and demonstrated compatibility between components. Also tested flexural durability of RFCB cables.
- Results: Pass - The sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the dimensional and cable durability requirements.
- Mechanical Performance: Verified specifications related to the mechanical interaction between the sEEG-RF Probe and Accessories.
- Results: Pass - The sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the mechanical performance requirements.
- Mechanical Integrity: Evaluated the mechanical durability of the sEEG-RF Probe Accessories.
- Results: Pass - The sEEG-RF Probe Accessories (Temperature Accessory and Radio Frequency Connector Box) designs meet the mechanical integrity requirements.
- Ablation System Performance: Evaluated specifications related to energy delivery and temperature accuracy of the OneRF Ablation System including durability after use.
- Results: Pass - The sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the system performance requirements.
- Generator System: Verified specifications related to the Generator and UI Software.
- Results: Pass - The Generator and UI Software designs meet the system performance requirements.
- Electrical Safety: Tested against applicable requirements of Electromagnetic Compatibility and Electrical Safety standards - IEC 60601-1, -2, -6 and IEC 60601-2-2.
- Results: Pass - Met applicable requirements.
- Temperature Accessory Kit and RFCB Package Integrity: Tested packaged device and labeling against conditions of packaging, shelf life, and distribution testing to ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980-16, ASTM 2096, ASTM F88without loss of function, sterility, or legibility.
- Results: Pass - The sEEG-RF Probe Accessories (Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility).
- Sterilization: Validated the sterilization process to demonstrate a minimum of SAL of 10^-6 for the product using Ethylene Oxide per ISO 11135.
- Results: Pass - All criteria passed and the sterilization cycle was validated.
- Usability - Summative Validation: Performed in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016.
- Results: Pass – The NeuroOne OneRF Ablation System has been found to be safe and effective for the intended users, uses, and use environments.
- Software: Presented in accordance with FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices "issued on: May 11, 2005). Also followed IEC 62304, as applicable.
- Results: Software analysis addressed applicable requirements.
- Cybersecurity: Performed on the OneRF Ablation System in accordance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" - Final Guidance October 2, 2014 and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff" - Draft Guidance April 7, 2022.
- Results: Cybersecurity analysis addressed applicable requirements.
- Biocompatibility: Components tested included sEEG Electrode (sEEG-RF Probe), Anchor Bolt, Cap with prolonged (>24 hours to 30 days) contact with tissue/bone; Strain Relief, Lock Band, Stylet Assembly, Electrode Tail, and Electrode Connector with limited (
§ 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).
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2023
NeuroOne Medical Technologies Corp. % John Doucet, Ph.D. Vice President, Regulatory Affairs - Neuromodulation and Evolving Technologies MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, District of Columbia 20001
Re: K231675
Trade/Device Name: OneRF Ablation System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD, GXI Dated: November 6, 2023 Received: November 6, 2023
Dear Dr. John Doucet:
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.
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"
1
(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 OS 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 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-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 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.
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-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. Digitally signed by Adam D. Adam D. Pierce -S Pierce -S Date: 2023.12.06 15:41:45 -05'00' Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
NeuroOne OneRF Radiofrequency Ablation System
Indications for Use (Describe)
The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
| 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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4
510(k) Summarv K231675
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K231675 |
|---|---|
| Date Prepared: | December 6, 2023 |
| Applicant: | NeuroOne Medical Technologies Corp. |
| 7599 Anagram Drive | |
| Eden Prairie, MN 55344 | |
| Phone: (952) 426-1383 | |
| E-mail: debk@nmtc1.com | |
| Contact Person: | Debra Kridner |
| Regulatory Affairs Consultant | |
| 7599 Anagram Drive | |
| Eden Prairie, MN 55344 |
SUBJECT DEVICE
| Trade/Device Name: | OneRF TM Ablation System |
|---|---|
| Device Regulation Number: | 21 CFR§882.4400 |
| 21 CFR§882.4725 | |
| Device/Regulation Name: | Radiofrequency Lesion Generator, Radiofrequency Lesion Probe |
| Product Code: | GXD |
| GXI | |
| Device Class/Regulation | |
| Classification: | Class II |
DEVICE DESCRIPTION (For the Device Subject to this 510(k) Premarket Notification)
OneRF™ Ablation System
The OneRF™ Ablation System components consist of the:
- Radiofrequency (RF) Generator and Accessories 1.
- Generator Interface Cable (GIC), Cart and Foot Pedal (optional) a.
-
- sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
- a. Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box
The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.
To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).
5
PREDICATE DEVICE
NeuroOne has chosen a Radiofrequency Lesion Generator as our primary predicate device; specifically, the Cosman G4 Radiofrequency Generator that received marketing authorization after FDA review of K082051 and was cleared under 21 CFR 882.4400 (product code GXD). This RF Generator was chosen as the primary predicate because it has the same intended use, namely lesioning nervous tissue for neurosurgical procedures and similar technological characteristics as the subject device generator.
A second predicate device Radiofrequency Lesion Probe was chosen as RF lesions can only be created with a RF Generator and RF Probe. This device is the Diros OWL RF Probe which received marketing authorization after FDA review of K010202 and was cleared under 21 CFR 882.4725 (product code GXI). To create an RF Ablation System this RF Probe was chosen as an additional predicate because it has the same intended use as NeuroOne's sEEG-RF Probe: namely, to be connected to an RF Generator for lesioning nervous tissue for neurosurgical procedures and similar technological characteristics as the subject device probe.
The predicate devices were chosen as the Intended Use is the same. The Indications for Use, Fundamental Scientific Technology, and Principles of Operation are either the same or if different did not raise new questions of safety and/or effectiveness when compared to the subject device.
INDICATIONS FOR USE
The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lessions in nervous tissue for functional neurosurgical procedures.
6
COMPARISON OF SUBJECT DEVICE (SYSTEM) TO PRIMARY PREDICATE DEVICE (RF GENERATOR) and PREDICATE (RF PROBE)
| Device Classification Comparison - Generator | |||
|---|---|---|---|
| Subject Device | Primary Predicate | ||
| Device | |||
| K082051 | Comparison | ||
| Same/Different | |||
| Trade/Device Name: | NeuroOne OneRFTM | ||
| Ablation System | |||
| Generator | Cosman RF | ||
| Generator | NA | ||
| Device Regulation | |||
| Number | 21 CFR§882.4400 | 21 CFR§882.4400 | Same |
| Device / Regulation | |||
| Name | Radiofrequency lesion | ||
| generator | Radiofrequency lesion | ||
| generator | Same | ||
| Device Regulation | |||
| 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. | 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. | Same | ||
| Product Codes | GXD | GXD | Same |
| Device Class / Regulation | |||
| Classification | Class II | Class II | Same |
DEVICE CLASSIFICATION COMPARISON - RF GENERATOR AND RF PROBE
| Device Classification Comparison - Probe | |||
|---|---|---|---|
| Subject | |||
| Device | Predicate Device | ||
| K010202 | Comparison | ||
| Same/Different | |||
| Trade/Device Name: | NeuroOne OneRFTM | ||
| Ablation System sEEG- | |||
| RF Probe | Diros RF Probe | NA | |
| Device Regulation | |||
| Number | 21 CFR§882.4725 | 21 CFR§882.4725 | Same |
| Device / Regulation | |||
| Name: | Radiofrequency lesion | ||
| probe | Radiofrequency lesion | ||
| probe | Same | ||
| Device Regulation | |||
| Identification | A radiofrequency lesion | ||
| probe is a device | |||
| connected to a | |||
| radiofrequency (RF) | |||
| lesion generator to | |||
| deliver the RF energy to | |||
| the site within the | |||
| nervous system where a | |||
| lesion is desired. | A radiofrequency lesion | ||
| probe is a device | |||
| connected to a | |||
| radiofrequency (RF) | |||
| lesion generator to deliver | |||
| the RF energy to the site | |||
| within the nervous system | |||
| where a lesion is desired. | Same | ||
| Product Codes | GXI | GXI | Same |
| Device Class / Regulation | |||
| Classification | Class II | Class II | Same |
7
INTENDED USE/INDICATIONS FOR USE COMPARISON TABLE – RF GENERATOR/RF PROBE (ABLATION SYSTEM)
| Intended Use/Indications for Use Comparison RF Generator and RF Probe (Ablation System) | |||
|---|---|---|---|
| Subject Device | |||
| (RF Ablation System) | |||
| K231675 | Primary Predicate | ||
| RF Generator K082051 and | |||
| Predicate RF Probe | |||
| K010202 | Comparison | ||
| Same/Different | |||
| Intended | |||
| Use | RF Ablation System consists of | ||
| a generator and probe used for | |||
| lesioning nervous tissue for | |||
| neurosurgical procedures. | RF Ablation System consists of | ||
| a generator and probe used for | |||
| lesioning nervous tissue for | |||
| neurosurgical procedures. | Same | ||
| Indications | |||
| for Use | The NeuroOne OneRFTM | ||
| Radiofrequency Ablation | |||
| System is indicated for creation | |||
| of radiofrequency lesions in | |||
| nervous tissue for functional | |||
| neurosurgical procedures. | RF Generator | ||
| The Cosman 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 | |||
| Cosman | |||
| G4 | |||
| Radiofrequency Generator is | |||
| used with separately approved | |||
| Cosman | |||
| Radiofrequency | |||
| Probes |
RF Probe
- Lesioning nerve tissue for
functional neurosurgical
procedures such as
thalamotomies, pallidotomies,
tractomies, and myelotomies;
or - radiofrequency heat lesion
procedures for the relief of pain | Different
Removed reference
to relief/treatment
of pain.
The subject device
indications for use
does not separately
define a specific
probe or generator
as they are defined
as part of the
NeuroOne system. |
8
| Technological and Performance Characteristics Comparison – RF Generator | |||
|---|---|---|---|
| Subject Device | Primary Predicate | ||
| Device K082051 | Comparison | ||
| Same/Different | |||
| Device name | NeuroOne OneRF™ | ||
| Generator | Cosman RF | ||
| Generator | N/A | ||
| RF Output Frequency | 465.1 kHz | 480 kHz | Different |
| Maximum output power | |||
| (Hardware) | 50 watts | 50 watts | Same |
| Maximum output power | |||
| (Software) | 2 watts | 50 watts | Different |
| Power delivery modes | Continuous and pulsed | Continuous and pulsed | Same |
| AC Power Compatibility | AC Line 100-240V | AC Line 100-240V | Same |
| Lesion Creation | Yes | Yes | Same |
| Temperature Monitoring | Yes | Yes | Same |
| Temperature Range (°C) | 20 to 90 | 0 to 110 | Different |
| Temperature Shut Off (°C) | 90 | >100 | Different |
| Auto shutdown for | |||
| temperature exceeding | |||
| safe levels | Yes | Yes | Same |
| Electrical safety/EMC | |||
| compliant | IEC 60601-1 and | ||
| IEC 60601-1-2 compliant | IEC 60601-1 and | ||
| IEC 60601-1-2 compliant | Same | ||
| RF energy delivery | |||
| modes: | ● Manual control | ||
| ● Temperature control | ● Manual control | ||
| ● Temperature control | Same | ||
| RF energy delivery | |||
| channel types | Monopolar | ||
| Bipolar | Monopolar | ||
| Bipolar | Same | ||
| User Touchscreen | |||
| Interface | Yes | Yes | Same |
| USB Port updating | |||
| software and | |||
| downloading logs | Yes | Yes | Same |
TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISON
9
| Technological and Performance Characteristics Comparison - RF Probe | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| K010202 | Comparison | ||
| Same/Different | |||
| Device name | NeuroOne OneRF™ | ||
| sEEG-RF Probe | Diros RF Probe | ||
| (Tasker Intracranial | |||
| Lesion Electrode) | N/A | ||
| RF Probe | |||
| Configuration | Single open lumen probe | ||
| (closed at tip) | Single closed lumen | ||
| probe | Same | ||
| Temperature | |||
| Measurement | |||
| Capabilities | Yes | Yes | Same |
| Location of | |||
| Temperature Sensor | On Temperature | ||
| Accessory (inserted into | |||
| lumen of probe) | Embedded in probe tip | Different | |
| Patient- Contact | |||
| Materials | Polyimide - electrode | ||
| Platinum - contact | Stainless steel | ||
| Insulation - (medical | |||
| grade, abrasion | |||
| resistant) | Different | ||
| Compatibility with RF | |||
| Generator | Yes, NeuroOne RF | ||
| Generator (using | |||
| adapters) | Yes, Diros and Cosman | ||
| RF Generators (using | |||
| legally marketed | |||
| adapters) | Same | ||
| Key Dimensions: | |||
| Electrode Active | |||
| Length | 2 mm | 2 mm | Same |
| Diameter | 0.8 mm | 0.8 mm | Same |
| Number of Contacts | 4 - 15 on each probe | ||
| enabled for Ablation | 1 on each probe | Different | |
| Creation of Lesions in | |||
| Nervous Tissue | Yes | Yes | Same |
| Comparative Lesion | |||
| Size Testing in Ex- | |||
| vivo Tissue | Yes | Yes | Same |
| System Characteristics | |
|---|---|
| System Characteristic | Identification |
| User | Neurosurgeons familiar with RF lesion techniques |
| Anatomical Site of | |
| Use | Nervous tissue |
| Access Method | Intracranial |
| EnergyType | Radiofrequency |
| Procedure Type | Ablation |
| Principle of Operation | Operator controlled; RF delivered from RF generator to compatible sEEG - RF probes to create lesions in nervous tissue |
| Mechanism ofAction | Cellular necrosis through thermal coagulation |
| System Feedback | |
| Mechanism | Temperature controlled |
| Ability to Make | |
| Multiple Lesions | Yes |
10
SUMMARY OF PERFORMANCE TESTING AND STANDARDS
The following performance data were provided in support of the substantial equivalence determination for the subject NeuroOne OneRF™ Ablation System. Performance testing of the subject device (system) was conducted to demonstrate that the device (system) meets its performance specifications. Results of design verification and validation activities did not raise any new or different questions of safety or effectiveness. The risk management process was used throughout the non-clinical verification activities in accordance with ISO 14971. The following tests/analysis were conducted.
| Non-Clinical Performance Tests | |||
|---|---|---|---|
| Test | Overview Summary | Results and Conclusions | |
| Lesion Size Testing | This testing was performed to | ||
| provide a measurement of the size | |||
| (width and length) of the lesion for | |||
| each active electrode contact: | |||
| temperature, time, configuration | |||
| (monopolar, bipolar), mode | |||
| (temperature control, manual). | Lesion sizes were determined based on time | ||
| and temperature. Lesion size is comparable | |||
| to predicate. | |||
| Dimensional | |||
| Verification and | |||
| RFCB Cable | |||
| Durability | This testing was performed to | ||
| evaluate the dimensional | |||
| characteristics and to demonstrate | |||
| compatibility between components. | |||
| In addition, the flexural durability of | |||
| the RFCB cables was tested. | Pass - The test results indicate that the | ||
| sEEG-RF Probe / Temperature Accessory / | |||
| Stylet / Spacer Tube and Radio Frequency | |||
| Connector Box designs meet the | |||
| dimensional and cable durability | |||
| requirements. | |||
| Mechanical | |||
| Performance | This testing was performed to verify | ||
| specifications related to the | |||
| mechanical interaction between the | |||
| sEEG-RF Probe and Accessories | Pass - The test results indicate that the | ||
| sEEG-RF Probe / Temperature Accessory / | |||
| Stylet / Spacer Tube and Radio Frequency | |||
| Connector Box designs meet the mechanical | |||
| performance requirements | |||
| Mechanical Integrity | This testing was performed to | ||
| evaluate the mechanical durability | |||
| of the sEEG-RF Probe | |||
| Accessories. | Pass - The test results indicate that the | ||
| sEEG-RF Probe Accessories (Temperature | |||
| Accessory and Radio Frequency Connector | |||
| Box) designs meet the mechanical integrity | |||
| requirements | |||
| Ablation System | |||
| Performance | The purpose of this testing is to | ||
| evaluate specifications related to | |||
| energy delivery and temperature | |||
| accuracy of the OneRF Ablation | |||
| System including durability after | |||
| use. | Pass - The test results indicate that the | ||
| sEEG-RF Probe / Temperature Accessory / | |||
| Stylet / Spacer Tube and Radio Frequency | |||
| Connector Box designs meet the system | |||
| performance requirements. | |||
| Generator System | This testing was performed to verify | ||
| specifications related to the | |||
| Generator and UI Software. | Pass - The test results indicate that the | ||
| Generator and UI Software designs meet the | |||
| system performance requirements. | |||
| Electrical Safety | Product shall meet the applicable | ||
| requirements of Electromagnetic | |||
| Compatibility and Electrical Safety | |||
| standards - IEC 60601-1, -2, -6 and | |||
| IEC 60601-2-2 | Pass - Met applicable requirements | ||
| Temperature | |||
| Accessory Kit and | |||
| RFCB Package | |||
| Integrity | The packaged device and labeling | ||
| shall withstand the conditions of | |||
| packaging, shelf life, and distribution | |||
| testing to ISO 11607-1, ISTA 3A, | |||
| ASTM D4169, ASTM F1980-16, | |||
| ASTM 2096, ASTM F88without loss | |||
| of function, sterility, or legibility. | Pass - The test results indicate that the | ||
| sEEG-RF Probe Accessories (Temperature | |||
| Accessory / Stylet / Spacer Tube and Radio | |||
| Frequency Connector Box) packaging | |||
| designs meet the integrity requirements (i.e., | |||
| seal strength, bubble leak, label inspection, | |||
| and no damage that impacts device sterility). | |||
| Sterilization | The sterilization process shall be | ||
| validated to demonstrate a | |||
| minimum of SAL of $10^{-6}$ for the | |||
| product using Ethylene Oxide per | |||
| ISO 11135 | Pass - All criteria passed and the sterilization | ||
| cycle was validated. | |||
| Usability - | |||
| Summative | |||
| Validation• | This testing was performed in | ||
| accordance with FDA guidance, | |||
| "Applying Human Factors and | |||
| Usability Engineering to Medical | |||
| Devices", February 3, 2016 | Pass – The NeuroOne OneRF™ Ablation | ||
| System has been found to be safe and | |||
| effective for the intended users, uses, and | |||
| use environments. | |||
| Software | Software was presented in | ||
| accordance with FDA Guidance | |||
| "Content of Premarket Submissions | |||
| for Software Contained in Medical | |||
| Devices "issued on: May 11, 2005). | |||
| In addition, IEC 62304 was | |||
| followed, as applicable | Software analysis addressed applicable | ||
| requirements | |||
| Cybersecurity | Cybersecurity analysis was | ||
| performed on the OneRF™ | |||
| Ablation System in accordance | |||
| with "Content of Premarket | |||
| Submissions for Management of | |||
| Cybersecurity in Medical Devices" |
- Final Guidance October 2, 2014
and "Cybersecurity in Medical
Devices: Quality System
Considerations and Content of
Premarket Submissions Draft
Guidance for Industry and Food
and Drug Administration Staff" -
Draft Guidance April 7, 2022. | Cybersecurity analysis addressed applicable
requirements | |
11
| Biocompatibility | |||
|---|---|---|---|
| Biocompatibility Overview | Conclusions | ||
| Components tested: sEEG Electrode (sEEG-RF Probe), Anchor Bolt, | |||
| Cap with prolonged (>24 hours to 30 days) contact with tissue/bone. | |||
| Components tested: Strain Relief, Lock Band, Stylet Assembly, | |||
| Electrode Tail, and Electrode Connector with limited ( |