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).

AI/ML Overview

The provided document is a 510(k) summary for the CellFX® nsPFA™ Percutaneous Electrode System, specifically focusing on the addition of an 18G electrode. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the information you're looking for regarding acceptance criteria, specific device performance metrics in comparison to those criteria, and detailed study methodologies in terms of sample sizes, expert ground truth establishment, and comparative effectiveness studies (MRMC) would typically be found in direct PMA (Premarket Approval) submissions or more comprehensive clinical study reports, not usually within a 510(k) summary.

However, I can extract the information that is present in the document which relates to performance and design control testing that supports the claim of substantial equivalence.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria or detailed device performance metrics in the format you requested (e.g., sensitivity, specificity, accuracy against a numerical threshold). Instead, it states that various tests "met their respective acceptance criteria" or "passed," indicating qualitative compliance with established standards.

Type of Testing	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
Biocompatibility Testing	Met respective acceptance criteria (per FDA Guidance, ISO 10993-1)	All tests for Pyrogenicity, Systemic Toxicity, Sensitization, Irritation, Cytotoxicity, and Hemolysis successful.
Electrical Safety and EMC Testing	Complies with IEC 60601-1, IEC 60601-1-2, 60601-2-2, IEC 60601-1-6, IEC 62366, and IEC 62304	All electrical safety and EMC tests passed.
Bench Testing	Performs as intended per its specifications	Performed as intended per its specifications.
Software Verification and Validation Testing	As recommended by FDA Guidance ("Content of Premarket Submissions for Device Software Functions," June 14, 2023) and ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," March 9, 2020)	Enhanced documentation level of software testing included, supports safety and effectiveness. Cybersecurity controls implemented to mitigate risk of malware.
Pre-Clinical Animal Safety and Performance Studies	Safety and performance for ablation of soft tissue	Data demonstrates and supports the CellFX nsPFA Percutaneous Electrode System is safe and effective for ablation of soft tissue.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified for any of the tests.
Data Provenance: The pre-clinical animal study is described as an "in vivo GLP animal safety study." This implies a prospective study conducted under Good Laboratory Practice (GLP) guidelines, but does not specify the country of origin. Other tests (biocompatibility, electrical safety, bench, software) are typically performed in a laboratory setting, and their "provenance" would be the testing facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

For Biocompatibility, Electrical Safety, Bench, Software Testing: The concept of "experts establishing ground truth" as it applies to clinical data is not relevant for these types of engineering and laboratory tests. Compliance is based on meeting predefined technical standards and specifications.
For Pre-Clinical Animal Safety and Performance Studies: The document doesn't specify the number or qualifications of experts involved in assessing the outcomes of the animal study. Conclusions would typically be drawn by veterinary pathologists or other scientific experts, but this detail is not provided.

4. Adjudication Method for the Test Set:

For Biocompatibility, Electrical Safety, Bench, Software Testing: Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies. For these tests, the outcome is determined by adherence to a standard or a pass/fail criterion, not by expert consensus on ambiguous findings.
For Pre-Clinical Animal Safety and Performance Studies: The document does not describe any specific adjudication method for the animal study results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices to assess how human reader performance changes with or without AI assistance. The CellFX system is an electrosurgical device for tissue ablation, not a diagnostic imaging device, so an MRMC study is not relevant to its regulatory pathway as described here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a physical electrosurgical system with associated software. The concept of "standalone performance" (algorithm only) as applicable to AI diagnostics (e.g., an algorithm interpreting images without human input) does not directly apply here. The software verification and validation testing assesses the software's performance within the integrated device system.

7. The Type of Ground Truth Used:

Biocompatibility: Adherence to established biological safety standards (e.g., ISO 10993-1).
Electrical Safety and EMC: Compliance with international electrical and electromagnetic compatibility standards (e.g., IEC 60601 series).
Bench Testing: Performance against predefined engineering specifications and functional requirements.
Software Verification and Validation Testing: Compliance with software development lifecycle processes and functional requirements as per FDA guidance.
Pre-Clinical Animal Safety and Performance Studies: Biological effects observed in animal tissue (e.g., lesion formation, cellular changes, lack of adverse events) in a GLP study. This is considered an in vivo biological ground truth in an animal model.

8. The Sample Size for the Training Set:

This document describes a device submission for an electrosurgical ablation system, not a machine learning or AI algorithm in the context of diagnostic image analysis where distinct training and test sets of patient data are typical.
Therefore, the concept of a "training set" in the context of machine learning model development is not directly applicable or discussed in this 510(k) summary for this type of medical device. The software component refers to system control and safety functions, not an AI diagnostic algorithm.

9. How the Ground Truth for the Training Set Was Established:

As explained in point 8, a "training set" for an AI algorithm is not referenced in this document.

Summary

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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"

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(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

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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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510(k) Summary

I. Submitter

Applicant:	Pulse Biosciences, Inc.3957 Point Eden WayHayward, CA 94545Phone: (833) 257-3393
Contact Person:	Uyen Mai, MSDirector, Regulatory Affairs, QA and QCPulse Biosciences, Inc.Phone: (510) 906-4691
Date Prepared:	August 1, 2024

II. DEVICE INFORMATION

Trade Name:	CellFX® nsPFA™ Percutaneous Electrode System with CellFXPercutaneous 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

This 510(k) supports the addition of the CellFX nsPFA Percutaneous Electrode, 18G, to the CellFX nsPFA Percutaneous Electrode family, which has smaller dimensions

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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® nsPFAPercutaneous ElectrodeSystem with CellFX nsPFAPercutaneous Electrode, 18G	CellFX® nsPFAPercutaneous ElectrodeSystem with CellFX nsPFAPercutaneous Electrode, 13G
Prescription Only	Yes	Yes
Regulation Number	878.4400	878.4400
Product Code	GEI	GEI
Indications For Use
Indications for UseStatement	Intended for ablation of softtissue in percutaneous andintraoperative surgicalprocedures. It is not intendedfor use in cardiacprocedures.	Intended for ablation of softtissue in percutaneous andintraoperative surgicalprocedures. It is not intendedfor use in cardiacprocedures.
Technological Characteristics
Components	RF Generator, ActiveElectrode, Adapter,Footswitch	RF Generator, ActiveElectrode, Adapter,Footswitch
Mechanism of Action	Nanosecond Pulse FieldAblation (nsPFA): ultrafastnanosecond electrical pulsesto the targeted tissue	Nanosecond Pulse FieldAblation (nsPFA): ultrafastnanosecond electrical pulsesto the targeted tissue
Output Frequency	1-10 Pulses per second	1-10 Pulses per second
PulseAmplitude/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

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	Subject Device (K240782)	Predicate Device (K233705)
	(when pulsing at 15kV pulse voltage with500 ns pulse width and 10 Hz pulsefrequency into a 75 Ohm load)	(when pulsing at 15kV pulse voltage with500 ns pulse width and 10 Hz pulsefrequency 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 -UseDevice	Single-Use	Single-Use
Biocompatibility	Patient-contacting materialsare biocompatible	Patient-contacting materialsare 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.

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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.

Regulation Number and Section

§ 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.