The Pulse Biosciences® CellFX® System is a proprietary platform technology. The CellFX System consists of the CellFX Console, CellFX Handpiece, CellFX Treatment Tips, and CellFX Software. The CellFX System delivers nanosecond duration electrical pulses that disrupt the function of cells leading to cell death, while sparing non-cellular tissue. The CellFX System delivers a series of timed, nanosecond electrical pulses (referred to as a "Cycle") to ablate and resurface tissue areas in dermatologic conditions.

The CellFX Console is capable of delivering short electric pulses at amplitudes up to 15 kV and pulse widths up to 700 ns. The electrical energy pulses are applied directly to targeted tissue using sterile Treatment Tips with stainless steel microneedles. The treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.

AI/ML Overview

The provided text describes the CellFX® System and its substantial equivalence to a predicate device, focusing on safety and performance, particularly concerning higher energy settings. However, it does not contain specific acceptance criteria with numerical targets, nor does it present a human reader study (MRMC) or a standalone algorithm performance study. The device is a physical electrosurgical system, not an AI/ML-driven diagnostic tool, which explains the absence of some of the requested information.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for performance metrics. Instead, it refers to general statements of acceptance met during various tests.

Acceptance Criteria (Stated Generally)	Reported Device Performance
Device performs as intended	All test articles met the acceptance criteria for device performance. The performance testing for the CellFX System (Console, Handpiece and Tip) verified that the CellFX System performed as intended and met product specifications.
Safety (e.g., no acute adverse events, acceptable healing, no effect on draining lymph nodes or non-target organs)	All CellFX treatments were successfully completed with no acute procedural adverse events. Pathology results support the safety of the CellFX System as there was acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs. The animal study data confirmed that the device performs as intended and does not raise safety concerns.
Performance (e.g., treatment zones achieving degeneration and necrosis of active treatment sites while epidermis remained intact)	The treatment zones met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended.
Biocompatibility	Biocompatibility testing was not required as there were no changes to the device compared to the predicate that would impact biocompatibility. (Implies predicate device previously met biocompatibility criteria)
Electrical safety and electromagnetic compatibility (EMC)	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 electrical safety and EMC tests passed.
Software Verification and Validation	Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance. Completed software testing supports the safety and effectiveness of the device. Cybersecurity controls implemented to mitigate risk. Considered a "moderate" level of concern.

2. Sample Size and Data Provenance

The only clinical-like study mentioned is an animal study.

Sample Size (Test Set): 15 Yucatan mini-pigs.
Data Provenance: Prospective animal study (Yucatan mini-pigs). The country of origin is not specified but is implicitly under US regulatory purview given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable as this was an animal study evaluating device performance and safety, not a diagnostic accuracy study requiring human expert interpretation of images or clinical data for ground truth. Ground truth would have been established through pathological examination and observation of healing in the animal models.

4. Adjudication Method for the Test Set

Not applicable. The animal study evaluated physiological and pathological responses to the device treatment, not a diagnostic outcome requiring adjudication of expert opinions. The assessment of pathological outcomes would typically involve veterinary pathologists.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is an electrosurgical system for ablation and resurfacing, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This device is a physical electrosurgical system, not a software algorithm or AI model designed for standalone diagnostic or analytical performance. Its "performance" refers to its physical operation and biological effects.

7. Type of Ground Truth Used

For the animal study:

Pathology: Evaluation of treatment zones (degeneration and necrosis), epidermal integrity, and effects on draining lymph nodes and non-target organs.
Outcomes Data: Observation of acute procedural adverse events and healing.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would relate to engineering design, testing, and validation, not data-driven model training.

9. How Ground Truth for the Training Set Was Established

Not applicable. As explained in point 8, there is no "training set" in the context of an AI/ML model for this type of device. The device's performance characteristics are established through engineering design, bench testing, and in vivo studies, where "ground truth" for these measurements is based on physical and biological principles.

Summary

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August 1, 2022

Pulse Biosciences, Inc. Punam Gollamudi Director US Regulatory Affairs 3957 Point Eden Way Hayward, California 94545

Re: K221671

Trade/Device Name: CellFX® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 8, 2022 Received: June 9, 2022

Dear Punam Gollamudi:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name CellFX® System

Indications for Use (Describe)

The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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

510(k) Summary

I. Submitter

Applicant:	Pulse Biosciences, Inc.3957 Point Eden WayHayward, CA 94545Phone: (510) 906-4649
Contact Person:	Punam GollamudiDirector of US Regulatory AffairsPulse Biosciences, Inc.Phone: (415) 305-4404
Date Prepared:	June 8, 2022

II. DEVICE INFORMATION

Trade Name:	CellFX® System
Regulation Number	21 CFR § 878.4400
Regulation Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Regulation Class:	Class II
Product Code:	GEI
Classification Panel:	General and Plastic Surgery

III. PREDICATE DEVICE

K211444 - CellFX® System, Pulse Biosciences, Inc. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE STATEMENT

The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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. The design, materials, and energy source remain the same. Based on the data provided, the higher energy densities do not raise any new or different questions of safety and effectiveness.

	Subject Device	Predicate Device (K211444)
Trade Name	CellFX® System	CellFX® System
Prescription Only	Yes	Yes
RegulationNumber	878.4400	878.4400
Product Code	GEI	GEI
Indications for Use
Indications for UseStatement	The CellFX System is intendedfor dermatological proceduresrequiring ablation and resurfacingof the skin.	The CellFX System is intended fordermatological proceduresrequiring ablation and resurfacingof the skin.
Technological Characteristics
Mechanism ofAction	Nano-Pulse Stimulation: ultrafastnanosecond electrical pulses tothe targeted tissue via treatmenttips with an array of microneedles	Nano-Pulse Stimulation: ultrafastnanosecond electrical pulses to thetargeted tissue via treatment tipswith an array of microneedles
Pulse Frequency	1 Hz -10 Hz	1 Hz -10 Hz
PulseAmplitude/Voltage	300V to 15kV	300V to 15kV
Pulse Width	100 ns - 700 ns	100 ns – 700 ns
Power Input	100-240 VAC, 50/60 Hz, 2A	100-240 VAC, 50/60 Hz, 2A
Power Output	30 Watts	30 Watts
Energy DensityRange	1.5 x 1.5 mm - 300-575 mJ/mm32.5 x 2.5 mm - 175-345 mJ/mm3	1.5 x 1.5 mm - 110-190 mJ/mm32.5 x 2.5 mm - 60-110 mJ/mm3

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Use of LocalAnesthesia	Yes	Yes
Sterile Tip	EO Sterilization	EO Sterilization
Handpiece	Universal Handpiece	Universal Handpiece
	System Physical Characteristics
Height	132 cm	132 cm
Length	46 cm	46 cm
Width	53 cm	53 cm
Weight	54 kg	54 kg
Power Input	100-240 VAC, 50/60 Hz, 2A	100-240 VAC, 50/60 Hz, 2A
	Tip Characteristics
Treatment Tip	2-Row	2-Row
MicroneedleConfiguration
1.5 x 1.5 mm	2 rows of 3 needles per row	2 rows of 3 needles per row
2.5 x 2.5 mm	2 rows of 4 needles per row	2 rows of 3 or 4 needles per row
5.0 x 5.0 mm	2 rows of 6 needles per row	2 rows of 4 or 6 needles per row
Tip Insertion Depth	1 mm and 2 mm	1 mm and 2 mm

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility testing was not required as there were no changes to the device compared to the predicated that would impact biocompatibility.

Electrical safety and electromagnetic compatibility (EMC)

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 testing for the CellFX System (Console, Handpiece and Tip) verified that the CellFX System performed as intended and met product specifications.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical

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Devices." The software for this device was considered as a "moderate" level of concern since a failure of the device could directly result in minor injury to the patient or operator. Completed software testing supports the safety and effectiveness of the device.

Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX System as recommended by FDA's Draft Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."

Animal Study

A GLP animal study was conducted to validate the safety and performance of the CellFX System.

Safety and Performance Evaluation of the CellFX® System Using High Energy Settings in Swine Skin

An animal study was conducted following GLP practices to characterize treatment zones across a range of higher energy settings to evaluate the safety and performance of the CellFX System. The study was conducted on 15 Yucatan mini-pigs that underwent skin treatments with the subject device including 2-Row CellFX Treatment Tips (1.5mm, 2.5mm, and 5.0mm).

Safetv

All CellFX treatments were successfully completed with no acute procedural adverse events. Pathology results support the safety of the CellFX System as there was acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs.

Performance

All test articles met the acceptance criteria for device performance. The treatment zones met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended.

Conclusion

CellFX treatments in the swine skin using higher energy levels for the Treatment Tips were shown to be safe and performed as intended. Therefore, this animal study data confirmed that the device performs as intended and does not raise safety concerns.

Summary

Based on the animal safety study, the CellFX System was found to have a safety and performance profile that is equivalent to the predicate device and does not raise any different questions of safety or effectiveness.

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CONCLUSION

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