The CellFX® 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.

Device Description

The CellFX® Percutaneous Electrode System includes the CellFX Console, CellFX Percutaneous Electrode 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 highamplitude 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.

AI/ML Overview

The provided text is an FDA 510(k) summary for the CellFX® Percutaneous Electrode System. It describes the device, its intended use, and the data presented to demonstrate its substantial equivalence to predicate devices. However, the document does not describe an AI/ML medical device.

Therefore, many of the requested points, such as "number of experts used to establish ground truth", "adjudication method", "MRMC comparative effectiveness study", "standalone algorithm performance", "sample size for training set", and "how ground truth for training set was established", are not applicable to this device's submission and are consequently not present in the provided text.

The device discussed is an electrosurgical cutting and coagulation device that uses nanosecond Pulsed Field Ablation (nsPFA) technology. Its performance is demonstrated through various traditional medical device validation methods, including biocompatibility testing, electrical safety and EMC testing, bench testing, software verification and validation, pre-clinical animal studies, and a human safety study.

Here's an attempt to answer the applicable points based on the provided text, while explicitly stating when information is not present or not relevant due to the device type:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" against specific "reported device performance" values in a quantitative manner for most tests. Instead, it states that tests "met their respective acceptance criteria" or "passed". For the human safety study, a quantitative result is provided.

Test Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility Testing	All tests meet respective acceptance criteria as per ISO 10993-1.	"All biocompatibility tests met their respective acceptance criteria."
Electrical Safety and Electromagnetic Compatibility (EMC) Testing	Compliance with IEC 60601-1, IEC 60601-1-2, 60601-2-2, 60601-1-6, IEC 62366, IEC 62304.	"All electrical safety and EMC tests passed."
Bench Testing	Device performs as intended per its specifications.	"The CellFX Percutaneous Electrode System performs as intended per its specifications."
Software Verification and Validation Testing	Software functions safely and effectively (enhanced documentation level). Cybersecurity controls mitigate risk.	"Software verification and validation testing were conducted and enhanced documentation was provided... supports the safety and effectiveness of the device." "Cybersecurity controls have been implemented to mitigate the risk..."
Pre-Clinical Animal Safety and Performance Studies	Demonstrate safety and performance for soft tissue ablation.	"The data provided... demonstrates and supports that the CellFX Percutaneous Electrode System is safe and effective for ablation of soft tissue..."
Human Safety Study	Demonstrate safety and effectiveness (though no specific quantitative criteria are listed).	"Subjects showed an average of 95% reduction in ablation zones by 30 days. No serious adverse events were observed."

2. Sample sized used for the test set and the data provenance

Test Set Sample Size:
- Human Safety Study: Ten (10) subjects.
- Pre-Clinical Animal Studies: "Two in vivo animal studies were conducted," but specific sample sizes for animals are not provided.
Data Provenance:
- The document implies the human safety study was conducted prospectively.
- The geographical origin of the data (country) is not explicitly stated. Given the FDA submission, it's likely US-based or data accepted by the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this device's performance is objective measurement (e.g., ablation zone reduction as measured by ultrasound in the human study, or physical/electrical parameters in bench testing, or pathological examination in animal studies).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. This concept is specifically relevant to human labeling or ground truth establishment in AI/ML performance studies. It is not relevant to the validation tests described for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done because this is not an AI/ML diagnostic or assistive device. The study performed was a human safety study of the device's direct clinical effect.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML algorithm. The device's performance is evaluated via its physical and biological effects.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Human Safety Study: Outcomes data primarily, specifically "average of 95% reduction in ablation zones" (likely measured clinically, possibly via imaging like ultrasound, and "No serious adverse events were observed."
Pre-Clinical Animal Studies: Likely involved pathological examination of ablated tissues for safety and effectiveness endpoints.
Bench Testing: Engineering specifications and performance measurements.
Biocompatibility/Electrical Safety: Standardized test methods specified by international standards (e.g., ISO, IEC).

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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March 8. 2024

Pulse Biosciences, Inc. Uyen Mai Director, Regulatory Affairs, Quality Assurance, and Quality Control 3957 Point Eden Way Hayward. California 94545

Re: K233705

Trade/Device Name: CellFX Percutaneous Electrode System (SYS3000) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2024 Received: February 5, 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" (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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 820.70) 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 mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.08 12:47:48 -05'00'

Mark Trumbore, 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) K233705

Device Name

CellFX Percutaneous Electrode System (SYS3000)

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:	November 16, 2023

DEVICE INFORMATION II.

CellFX® Percutaneous Electrode System Trade Name:

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

K190052 - Surgnova Healthcare Technologies (Zhejiang) Co., Ltd, Radio Frequency Ablation System

Reference Devices K052796 - Valleylab Cool-tip RF Ablation System and K203299 – CellFX System

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE STATEMENT

The CellFX® 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; therefore, even though the CellFX Percutaneous Electrode System has different technological characteristics than the predicate device, based on the data provided, the CellFX Percutaneous Electrode System does not raise any new or different questions of safety and effectiveness.

	Subject Device	PredicateDevice(K190052)	Ref Device(K052796)	Ref Device(K203299)
Trade Name	CellFX® PercutaneousElectrode System	Dolphi RFR150EAblationSystem	Valleylab Cool-tip RF AblationSystem	CellFXSystem
Prescription Only	Yes	Yes	Yes	Yes
Regulation	878.4400	878.4400	878.4400	878.4400
Product Code	GEI	GEI	GEI	GEI
		Indications for Use
Indications forUse Statement	Intended for ablation ofsoft tissue inpercutaneous andintraoperative surgicalprocedures. It is notintended for use incardiac procedures.	Intended forcoagulation andablation of softtissue. It is notintended foruse in cardiacprocedures.	Intended for theuse inpercutaneous,laparoscopic, andintraoperativecoagulation andablation of tissue.	Intended forablation andresurfacingof the skin.
		Technological Characteristics
Components	RF Generator, ActiveElectrode, Adapter,Footswitch	RadioFrequencyGenerator,RadioFrequencyElectrode Kits,TemperatureProbe, and FootSwitch	RF Generator,peristaltic pump,electrodes,inflow/outflowtubing, and returnpads	RFGenerator,Handpiece,Treatmenttips
Mechanism ofAction	Nanosecond PulseField Ablation(nsPFA): ultrafastnanosecond electrical	Radiofrequency current forablation of softtarget tissue	Radiofrequencycurrent forablation of softtarget tissue	Same asSubjectDevice
	Subject Device	PredicateDevice(K190052)	Ref Device(K052796)	Ref Device(K203299)	K233705
	pulses to the targetedtissue
Output Frequency	1-10 Pulses per second	470kHz	480kHz±10%	Same asSubjectDevice
PulseAmplitude/Voltage	800V to 15kV	Up to 200 watts@50 ohm	Up to 200 watts@50 ohm	Same asSubjectDevice
Pulse Width	100 ns – 500 ns	N/A	N/A	Same asSubjectDevice
Power Input	100-240 VAC, 50/60 Hz,2A	100-240 VAC,50/60 Hz	100-240 VAC,50/60 Hz	Same asSubjectDevice
Max PowerOutput	15 Watts(when pulsing at 15kV pulse voltage with500 ns pulse width and 10 Hz pulsefrequency into a 75 Ohm load)	Up to 200Watts@50ohms	0-200 watts maxoutput @ 50 ohmload	Same asSubjectDevice
		Active Electrodes
Energy Output	Bipolar RF	Monopolar RF	Monopolar RF	Same asSubjectDevice
Electrode Length(mm)	95	70, 150, 200,250	100, 144, 150,200, 250	Same asSubjectDevice
Exposure Length(mm)	14	5, 7, 10, 15, 20,30, 40	7, 10, 20, 30	Same asSubjectDevice
Outer Diameter(mm)	2.4	1.2, 1.47	1.2	Same asSubjectDevice
Tip Type	Trocar	Trocar	Trocar	MicroneedleArray
Material	Stainless Steel 304	Stainless Steel304	Stainless Steel304	Same asSubjectDevice
Disposable/Singe -Use Device	Single-Use	Single-Use	Single-Use	Same asSubjectDevice
	Subject Device	PredicateDevice(K190052)	Ref Device(K052796)	Ref Device(K203299)
Biocompatibility	Patient-contactingmaterials arebiocompatible	Patient-contactingmaterials arebiocompatible	Patient-contactingmaterials arebiocompatible	Same asSubjectDevice
Sterility	EO Sterilization	EOSterilization	EO sterilization	Same asSubjectDevice
System Physical Characteristics
Voltage Supply	100-240 VAC, 50/60Hz, 2A	100-240 VAC, 50/60 Hz, 2A	100-240 VAC, 50/60 Hz, 2A	Same asSubjectDevice

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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 Percutaneous Electrode.

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 Percutaneous Electrode System performs as intended per its specifications.

Software Verification and Validation Testing

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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 Percutaneous Electrode System 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," two in vivo animal studies were conducted to support the safety and performance of the CellFX Percutaneous Electrode System. Based on the in vivo animal safety studies, the data provided in this submission demonstrates and supports that the CellFX Percutaneous Electrode System is safe and effective for ablation of soft tissue and is substantially equivalent to the predicate device.

Human Safety Study

A prospective single-arm clinical study of ten (10) subjects was completed to demonstrate safety and effectiveness of the CellFX Percutaneous Electrode System. Two to four ablation zones were completed in benign thyroid nodules under ultrasound guidance and subjects were followed at 30 and 90 days post-treatment. Subjects showed an average of 95% reduction in ablation zones by 30 days. No serious adverse events were observed. Overall, the findings of this study provided strong evidence of the safety and effectiveness of the system in a surgical application in soft tissue.

Summary

The performance testing in pre-clinical and clinical safety studies was conducted to ensure that the CellFX Percutaneous Electrode System performs as intended per its specifications. CellFX Percutaneous Electrode System treatments are deemed nonthermal and did not result in any safety concerns during its intended use. Therefore, the performance testing verified that the device performs as intended and that the tested energy settings and treatment profile in soft tissue does not raise any different questions of safety or effectiveness.

VIII. CONCLUSION

The CellFX® Percutaneous Electrode System has the same indication for use, technological characteristics and principles of operation as the predicate device. The non-clinical performance testing, in vivo animal data, and clinical performance study data provided in this submission demonstrate and support that the CellFX Percutaneous Electrode System performs as intended and is as safe and as effective as the predicate device. Therefore, the CellFX Percutaneous Electrode System 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.