(137 days)
No
The summary describes an energy-based ablation system and its components, focusing on electrical pulses and physical characteristics. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The software mentioned is for system control and safety, not for AI/ML functions.
Yes
The device is intended for "ablation of soft tissue in percutaneous and intraoperative surgical procedures," which directly performs a medical treatment or procedure.
No
The device is intended for the ablation of soft tissue, indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the system includes hardware components such as the CellFX Console, Percutaneous Electrodes, Percutaneous Adapter, and pneumatic footswitch, in addition to the system software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ablation of soft tissue in percutaneous and intraoperative surgical procedures." This describes a procedure performed directly on a patient's tissue within the body, not on samples taken from the body.
- Device Description: The device is an energy-based system that delivers electrical energy to tissue via electrodes. This is a therapeutic device designed to modify tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to ablate tissue, not to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac procedures.
Product codes
GEI
Device Description
The CellFX® nsPFA™ Percutaneous Electrode System includes the CellFX Console, a family of CellFX nsPFA Percutaneous Electrodes (13G and 18G) and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.
This 510(k) supports the addition of the CellFX nsPFA Percutaneous Electrode, 18G, to the CellFX nsPFA Percutaneous Electrode family, which has smaller dimensions compared to that of the currently cleared CellFX nsPFA Percutaneous Electrode, 13G (K233705).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous and intraoperative surgical procedures
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)
Biocompatibility Testing:
The testing was conducted in accordance with FDA Guidance, issued September 4, 2020: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." All biocompatibility tests met their respective acceptance criteria, for each of the following tests:
- Pyrogenicity, Material Mediated
- Systemic Toxicity
- Sensitization
- Irritation
- Cytotoxicity
- Hemolysis
The biocompatibility test results successfully demonstrate biocompatibility of the CellFX nsPFA Percutaneous Electrode, 18G.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
The CellFX System complies with IEC 60601-1, IEC 60601-1-2, 60601-2-2, IEC 60601-1-6. IEC 62366, and IEC 62304. All test conditions were performed as outlined within the IEC standards. All electrical safety and EMC tests passed.
Bench Testing:
The performance bench testing was conducted to ensure that the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G performs as intended per its specifications.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and enhanced documentation was provided as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023. The intended use of this device is for general surgical procedures and in accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued on March 9, 2020, an enhanced documentation level of software testing was included in this 510(k) that supports the safety and effectiveness of the device. Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G, as recommended by FDA's Guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on September 27, 2023.
Pre-Clinical Animal Safety and Performance Studies:
In accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," an in vivo GLP animal safety study was conducted to support the safety and performance of the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G. Based on the in vivo GLP animal safety study, the data provided in this submission demonstrates and supports that the CellFX nsPFA Percutaneous Electrode System is safe and effective for ablation of soft tissue and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
August 5, 2024
Pulse Biosciences, Inc. Uyen Mai Director, Regulatory Affairs, Quality Assurance, & Ouality Control 3957 Point Eden Way Hayward, California 94545
Re: K240782
Trade/Device Name: CellFX Percutaneous Electrode System (SYS3000): CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 8, 2024 Received: July 9, 2024
Dear Uyen Mai:
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 reguires device manufacturers to review and approve changes to device design and production (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-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-reporting-mdr-howreport-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website 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.
Long H. Chen -SDDate: 2024.08.05 08:45:04 -04'00'
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
2
Indications for Use
510(k) Number (if known) K240782
Device Name
CellFX nsPFA Percutaneous Electrode System (SYS3000) CellFX nsPFA Percutaneous Electrode, 13G CellFX nsPFA Percutaneous Electrode, 18G
Indications for Use (Describe)
The CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac 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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3
510(k) Summary
I. Submitter
| Applicant: | Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward, CA 94545
Phone: (833) 257-3393 |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Uyen Mai, MS
Director, Regulatory Affairs, QA and QC
Pulse Biosciences, Inc.
Phone: (510) 906-4691 |
| Date Prepared: | August 1, 2024 |
II. DEVICE INFORMATION
| Trade Name: | CellFX® nsPFA™ Percutaneous Electrode System with CellFX
Percutaneous Electrode, 18G |
|-----------------------|-----------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR § 878.4400 |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Class: | Class II |
| Product Code: | GEI |
| Classification Panel: | General and Plastic Surgery |
III. PREDICATE DEVICE
K233705 - CellFX® nsPFA™ Percutaneous Electrode System
IV. DEVICE DESCRIPTION
The CellFX® nsPFA™ Percutaneous Electrode System includes the CellFX Console, a family of CellFX nsPFA Percutaneous Electrodes (13G and 18G) and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.
This 510(k) supports the addition of the CellFX nsPFA Percutaneous Electrode, 18G, to the CellFX nsPFA Percutaneous Electrode family, which has smaller dimensions
4
compared to that of the currently cleared CellFX nsPFA Percutaneous Electrode, 13G (K233705).
V. INDICATIONS FOR USE STATEMENT
The CellFX® nsPFA Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures. It is not intended for use in cardiac procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
To support a determination of substantial equivalence, Pulse Biosciences performed verification and validation testing demonstrating the subject device performs as intended; based on the data provided, the CellFX nsPFA Percutaneous Electrode System does not raise any new or different questions of safety and effectiveness.
| Subject Device (K240782) | Predicate Device (K233705) | |||
|---|---|---|---|---|
| Trade Name | CellFX® nsPFA | |||
| Percutaneous Electrode | ||||
| System with CellFX nsPFA | ||||
| Percutaneous Electrode, 18G | CellFX® nsPFA | |||
| Percutaneous Electrode | ||||
| System with CellFX nsPFA | ||||
| Percutaneous Electrode, 13G | ||||
| Prescription Only | Yes | Yes | ||
| Regulation Number | 878.4400 | 878.4400 | ||
| Product Code | GEI | GEI | ||
| Indications For Use | ||||
| Indications for Use | ||||
| Statement | Intended for ablation of soft | |||
| tissue in percutaneous and | ||||
| intraoperative surgical | ||||
| procedures. It is not intended | ||||
| for use in cardiac | ||||
| procedures. | Intended for ablation of soft | |||
| tissue in percutaneous and | ||||
| intraoperative surgical | ||||
| procedures. It is not intended | ||||
| for use in cardiac | ||||
| procedures. | ||||
| Technological Characteristics | ||||
| Components | RF Generator, Active | |||
| Electrode, Adapter, | ||||
| Footswitch | RF Generator, Active | |||
| Electrode, Adapter, | ||||
| Footswitch | ||||
| Mechanism of Action | Nanosecond Pulse Field | |||
| Ablation (nsPFA): ultrafast | ||||
| nanosecond electrical pulses | ||||
| to the targeted tissue | Nanosecond Pulse Field | |||
| Ablation (nsPFA): ultrafast | ||||
| nanosecond electrical pulses | ||||
| to the targeted tissue | ||||
| Output Frequency | 1-10 Pulses per second | 1-10 Pulses per second | ||
| Pulse | ||||
| Amplitude/Voltage | 800V to 15kV | 800V to 15kV | ||
| Pulse Width | 100 ns - 500 ns | 100 ns - 500 ns | ||
| Power Input | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50/60 Hz, 2A | ||
| Max Power Output | 15 Watts | 15 Watts |
5
| Subject Device (K240782) | Predicate Device (K233705) | |
|---|---|---|
| (when pulsing at 15kV pulse voltage with | ||
| 500 ns pulse width and 10 Hz pulse | ||
| frequency into a 75 Ohm load) | (when pulsing at 15kV pulse voltage with | |
| 500 ns pulse width and 10 Hz pulse | ||
| frequency into a 75 Ohm load) | ||
| Energy Output | Bipolar RF | Bipolar RF |
| Electrode Length (mm) | 95 | 95 |
| Exposure Length (mm) | 12 | 14 |
| Outer Diameter (mm) | 1.47 | 2.4 |
| Tip Type | Trocar | Trocar |
| Material | Stainless Steel 304 | Stainless Steel 304 |
| Disposable/Singe -Use | ||
| Device | Single-Use | Single-Use |
| Biocompatibility | Patient-contacting materials | |
| are biocompatible | Patient-contacting materials | |
| are biocompatible | ||
| Sterility | EO Sterilization | EO Sterilization |
| Systemic Physical Characteristics | ||
| Voltage Supply | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50/60 Hz, 2A |
VII. PERFORMANCE DATA
The following performance data was referenced or provided in support of the substantial equivalence determination.
Biocompatibility Testing
The testing was conducted in accordance with FDA Guidance, issued September 4, 2020: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." All biocompatibility tests met their respective acceptance criteria, for each of the following tests:
- · Pyrogenicity, Material Mediated
- · Systemic Toxicity
- · Sensitization
- Irritation
- · Cytotoxicity
- Hemolysis
The biocompatibility test results successfully demonstrate biocompatibility of the CellFX nsPFA Percutaneous Electrode, 18G.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
The CellFX System complies with IEC 60601-1, IEC 60601-1-2, 60601-2-2, IEC 60601-1-6. IEC 62366, and IEC 62304. All test conditions were performed as outlined within the IEC standards. All electrical safety and EMC tests passed.
6
Bench Testing
The performance bench testing was conducted to ensure that the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G performs as intended per its specifications.
Software Verification and Validation Testing
Software verification and validation testing were conducted and enhanced documentation was provided as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023. The intended use of this device is for general surgical procedures and in accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued on March 9, 2020, an enhanced documentation level of software testing was included in this 510(k) that supports the safety and effectiveness of the device.
Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G, as recommended by FDA's Guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on September 27, 2023
Pre-Clinical Animal Safety and Performance Studies
In accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," an in vivo GLP animal safety study was conducted to support the safety and performance of the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G. Based on the in vivo GLP animal safety study, the data provided in this submission demonstrates and supports that the CellFX nsPFA Percutaneous Electrode System is safe and effective for ablation of soft tissue and is substantially equivalent to the predicate device.
VIII. CONCLUSION
The CellFX® nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G, has the same indication for use, technological characteristics and principles of operation as the predicate device. The summary of design control activities provided in this submission demonstrates and supports that the CellFX nsPFA Percutaneous Electrode System performs as intended and is as safe and as effective as the predicate device. Therefore, the CellFX nsPFA Percutaneous Electrode System with CellFX nsPFA Percutaneous Electrode, 18G, is substantially equivalent to the predicate device.